U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
During packaging testing, baxter observed tears and pinholes in chevron-style pouches for certain infusion disposable products. the pinholes and tears could compromise the sterile barrier properties of the pouch.
Acción
Baxter Healthcare Corporation sent an Urgent Product Recall letter dated September 9, 2010, to all customers. The letter identified the product, the problem and the action to be taken by the customer. The customers were requested to examine their inventory in all locations to determine if they had any of the affected lots of the affected product codes and to remove the affected product from their inventory; they were to call the Baxter Healthcare Center for Service at 1-888-229-0001 to return the affected product, request a credit, or request replacement product; complete the attached customer reply form confirming their receipt of the letter and fax it to Baxter at the number provided on the form. Dealers, wholesalers and distributors were requested to notify their customers of this action so they could comply with the procedures listed above. Any questions regarding the communication were directed to The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
During packaging testing, baxter observed tears and pinholes in chevron-style pouches for certain infusion disposable products. the pinholes and tears could compromise the sterile barrier properties of the pouch.
Acción
Baxter Healthcare Corporation sent an Urgent Product Recall letter dated September 9, 2010, to all customers. The letter identified the product, the problem and the action to be taken by the customer. The customers were requested to examine their inventory in all locations to determine if they had any of the affected lots of the affected product codes and to remove the affected product from their inventory; they were to call the Baxter Healthcare Center for Service at 1-888-229-0001 to return the affected product, request a credit, or request replacement product; complete the attached customer reply form confirming their receipt of the letter and fax it to Baxter at the number provided on the form. Dealers, wholesalers and distributors were requested to notify their customers of this action so they could comply with the procedures listed above. Any questions regarding the communication were directed to The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
There are reagent barcode read errors when using reagent lot 86599m500 due to the print quality of the barcode.
Acción
Abbott Laboratories sent a "Product Recall Immediate Action Required" letter dated September 7, 2010, to all customers. The letter described product, problem and action to be taken by customers. The customers were instructed to determine if they are currently using and/or have inventory of lot 86599M500; discontinue use of and destroy any remaining inventory; inform and provide copies of letter to other laboratories if appropriate; retain the letter for laboratory records and complete and return the Customer Reply Immediate Action Required form via fax at 1-800-777-0051 or email QAGCO@abbott.com.
IMPORTANT NOTE: If you do not currently have replacement material than you may continue to use this reagent lot until your laboratory receives replacement material. Upon receipt of the replacement material, discontinue use of and discard lot 86599M500 and switch to the replacement material. Contact Abbott Customer service for replacement material (1-877-4ABBOTT, Option 1).
If you or any of the health care providers you serve have any questions regarding this information, U.S. customers should call Customers Service at 1-877-4ABBOTT. Customers outside of the U.S., please contact your local Customer Service representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Tubing packs may contain defective 1/2 inch x 1/2 inch tubing connectors. leaks at the shank of the connector may result in air aspiration in the venous line.
Acción
Maquet Getigne Group issued Product Recall/Urgent Medical Device Corrective Action letters dated September 7, 2010 to customers, identifying the affected product, the issue prompting the recall, and actions to be taken by customers.Customers are to check their inventory for affected product. Customers with affected product are to contact Laura Olilver at 201-995-8849 for an RMA number and shipment instructions. All firms are to coomplete and return the Corrective Action Response Form.
Maquet Customer Service can bre contacted at 800-777-4222.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The results of an investigation into complaints revealed that trabecular metal humeral and/or zimmer¿ trabecular metal reverse humeral implants engaging in the canal earlier than expected could lead to incomplete seating of the implant, delay in surgery, humeral fracture, or the need for cement in a press-fit application.
Acción
Zimmer, Inc. sent an URGENT DEVICE CORRECTION letter dated September 10, 2010 to surgeons, risk managers, and distributors. The letter identified the product, the problem, and the action to be taken. Sales Representatives were instructed to:
a. provide the Dear Surgeon (Urgent Device Correction) letter and revised
surgical technique directly to surgeons and risk managers at facilities using
the device or
b. provide a list of facilities and surgeons using the TM Humeral and TM
Reverse shoulder systems to the Zimmer Recall Coordinator, and
c. destroy previous versions of the surgical technique, and
d. inform users of when the new surgical technique, instrument case, distal
reamers, and distal pilots will be shipped to them based on communication
from Zimmer, Inc.
Handling of returned product:
HCPs were notified to return all of the distal pilots in the scope back to
Zimmer which were to be be destroyed once the recall has been completed. They will
also be instructed to either return the reamers back to Zimmer or to remove these reamers from the TM Reverse shoulder systems sets and place into the
Bigliani/Flatow Complete Shoulder Solution set. New surgical techniques will also be introduced and the user will be asked to remove previous versions of the surgical technique from all points of use. This removal will be verified by
Zimmer Sales Representatives.
For questions regarding this recall call (574) 371-8852.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The results of an investigation into complaints revealed that trabecular metal humeral and/or zimmer¿ trabecular metal reverse humeral implants engaging in the canal earlier than expected could lead to incomplete seating of the implant, delay in surgery, humeral fracture, or the need for cement in a press-fit application.
Acción
Zimmer, Inc. sent an URGENT DEVICE CORRECTION letter dated September 10, 2010 to surgeons, risk managers, and distributors. The letter identified the product, the problem, and the action to be taken. Sales Representatives were instructed to:
a. provide the Dear Surgeon (Urgent Device Correction) letter and revised
surgical technique directly to surgeons and risk managers at facilities using
the device or
b. provide a list of facilities and surgeons using the TM Humeral and TM
Reverse shoulder systems to the Zimmer Recall Coordinator, and
c. destroy previous versions of the surgical technique, and
d. inform users of when the new surgical technique, instrument case, distal
reamers, and distal pilots will be shipped to them based on communication
from Zimmer, Inc.
Handling of returned product:
HCPs were notified to return all of the distal pilots in the scope back to
Zimmer which were to be be destroyed once the recall has been completed. They will
also be instructed to either return the reamers back to Zimmer or to remove these reamers from the TM Reverse shoulder systems sets and place into the
Bigliani/Flatow Complete Shoulder Solution set. New surgical techniques will also be introduced and the user will be asked to remove previous versions of the surgical technique from all points of use. This removal will be verified by
Zimmer Sales Representatives.
For questions regarding this recall call (574) 371-8852.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The results of an investigation into complaints revealed that trabecular metal humeral and/or zimmer¿ trabecular metal reverse humeral implants engaging in the canal earlier than expected could lead to incomplete seating of the implant, delay in surgery, humeral fracture, or the need for cement in a press-fit application.
Acción
Zimmer, Inc. sent an URGENT DEVICE CORRECTION letter dated September 10, 2010 to surgeons, risk managers, and distributors. The letter identified the product, the problem, and the action to be taken. Sales Representatives were instructed to:
a. provide the Dear Surgeon (Urgent Device Correction) letter and revised
surgical technique directly to surgeons and risk managers at facilities using
the device or
b. provide a list of facilities and surgeons using the TM Humeral and TM
Reverse shoulder systems to the Zimmer Recall Coordinator, and
c. destroy previous versions of the surgical technique, and
d. inform users of when the new surgical technique, instrument case, distal
reamers, and distal pilots will be shipped to them based on communication
from Zimmer, Inc.
Handling of returned product:
HCPs were notified to return all of the distal pilots in the scope back to
Zimmer which were to be be destroyed once the recall has been completed. They will
also be instructed to either return the reamers back to Zimmer or to remove these reamers from the TM Reverse shoulder systems sets and place into the
Bigliani/Flatow Complete Shoulder Solution set. New surgical techniques will also be introduced and the user will be asked to remove previous versions of the surgical technique from all points of use. This removal will be verified by
Zimmer Sales Representatives.
For questions regarding this recall call (574) 371-8852.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The results of an investigation into complaints revealed that trabecular metal humeral and/or zimmer¿ trabecular metal reverse humeral implants engaging in the canal earlier than expected could lead to incomplete seating of the implant, delay in surgery, humeral fracture, or the need for cement in a press-fit application.
Acción
Zimmer, Inc. sent an URGENT DEVICE CORRECTION letter dated September 10, 2010 to surgeons, risk managers, and distributors. The letter identified the product, the problem, and the action to be taken. Sales Representatives were instructed to:
a. provide the Dear Surgeon (Urgent Device Correction) letter and revised
surgical technique directly to surgeons and risk managers at facilities using
the device or
b. provide a list of facilities and surgeons using the TM Humeral and TM
Reverse shoulder systems to the Zimmer Recall Coordinator, and
c. destroy previous versions of the surgical technique, and
d. inform users of when the new surgical technique, instrument case, distal
reamers, and distal pilots will be shipped to them based on communication
from Zimmer, Inc.
Handling of returned product:
HCPs were notified to return all of the distal pilots in the scope back to
Zimmer which were to be be destroyed once the recall has been completed. They will
also be instructed to either return the reamers back to Zimmer or to remove these reamers from the TM Reverse shoulder systems sets and place into the
Bigliani/Flatow Complete Shoulder Solution set. New surgical techniques will also be introduced and the user will be asked to remove previous versions of the surgical technique from all points of use. This removal will be verified by
Zimmer Sales Representatives.
For questions regarding this recall call (574) 371-8852.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The results of an investigation into complaints revealed that trabecular metal humeral and/or zimmer¿ trabecular metal reverse humeral implants engaging in the canal earlier than expected could lead to incomplete seating of the implant, delay in surgery, humeral fracture, or the need for cement in a press-fit application.
Acción
Zimmer, Inc. sent an URGENT DEVICE CORRECTION letter dated September 10, 2010 to surgeons, risk managers, and distributors. The letter identified the product, the problem, and the action to be taken. Sales Representatives were instructed to:
a. provide the Dear Surgeon (Urgent Device Correction) letter and revised
surgical technique directly to surgeons and risk managers at facilities using
the device or
b. provide a list of facilities and surgeons using the TM Humeral and TM
Reverse shoulder systems to the Zimmer Recall Coordinator, and
c. destroy previous versions of the surgical technique, and
d. inform users of when the new surgical technique, instrument case, distal
reamers, and distal pilots will be shipped to them based on communication
from Zimmer, Inc.
Handling of returned product:
HCPs were notified to return all of the distal pilots in the scope back to
Zimmer which were to be be destroyed once the recall has been completed. They will
also be instructed to either return the reamers back to Zimmer or to remove these reamers from the TM Reverse shoulder systems sets and place into the
Bigliani/Flatow Complete Shoulder Solution set. New surgical techniques will also be introduced and the user will be asked to remove previous versions of the surgical technique from all points of use. This removal will be verified by
Zimmer Sales Representatives.
For questions regarding this recall call (574) 371-8852.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The results of an investigation into complaints revealed that trabecular metal humeral and/or zimmer¿ trabecular metal reverse humeral implants engaging in the canal earlier than expected could lead to incomplete seating of the implant, delay in surgery, humeral fracture, or the need for cement in a press-fit application.
Acción
Zimmer, Inc. sent an URGENT DEVICE CORRECTION letter dated September 10, 2010 to surgeons, risk managers, and distributors. The letter identified the product, the problem, and the action to be taken. Sales Representatives were instructed to:
a. provide the Dear Surgeon (Urgent Device Correction) letter and revised
surgical technique directly to surgeons and risk managers at facilities using
the device or
b. provide a list of facilities and surgeons using the TM Humeral and TM
Reverse shoulder systems to the Zimmer Recall Coordinator, and
c. destroy previous versions of the surgical technique, and
d. inform users of when the new surgical technique, instrument case, distal
reamers, and distal pilots will be shipped to them based on communication
from Zimmer, Inc.
Handling of returned product:
HCPs were notified to return all of the distal pilots in the scope back to
Zimmer which were to be be destroyed once the recall has been completed. They will
also be instructed to either return the reamers back to Zimmer or to remove these reamers from the TM Reverse shoulder systems sets and place into the
Bigliani/Flatow Complete Shoulder Solution set. New surgical techniques will also be introduced and the user will be asked to remove previous versions of the surgical technique from all points of use. This removal will be verified by
Zimmer Sales Representatives.
For questions regarding this recall call (574) 371-8852.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The results of an investigation into complaints revealed that trabecular metal humeral and/or zimmer¿ trabecular metal reverse humeral implants engaging in the canal earlier than expected could lead to incomplete seating of the implant, delay in surgery, humeral fracture, or the need for cement in a press-fit application.
Acción
Zimmer, Inc. sent an URGENT DEVICE CORRECTION letter dated September 10, 2010 to surgeons, risk managers, and distributors. The letter identified the product, the problem, and the action to be taken. Sales Representatives were instructed to:
a. provide the Dear Surgeon (Urgent Device Correction) letter and revised
surgical technique directly to surgeons and risk managers at facilities using
the device or
b. provide a list of facilities and surgeons using the TM Humeral and TM
Reverse shoulder systems to the Zimmer Recall Coordinator, and
c. destroy previous versions of the surgical technique, and
d. inform users of when the new surgical technique, instrument case, distal
reamers, and distal pilots will be shipped to them based on communication
from Zimmer, Inc.
Handling of returned product:
HCPs were notified to return all of the distal pilots in the scope back to
Zimmer which were to be be destroyed once the recall has been completed. They will
also be instructed to either return the reamers back to Zimmer or to remove these reamers from the TM Reverse shoulder systems sets and place into the
Bigliani/Flatow Complete Shoulder Solution set. New surgical techniques will also be introduced and the user will be asked to remove previous versions of the surgical technique from all points of use. This removal will be verified by
Zimmer Sales Representatives.
For questions regarding this recall call (574) 371-8852.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Accelerator, linear, medical - Product Code IYE
Causa
It is possible to do couch corrections twice if both couch move assistant in mosaiq and remote automatic table in xvi are configured when in synergistiq mode.
Acción
Elekta sent an "Important Notice A340" dated September 1, 2010 to all customers. The notice described the product, problem and actions to be taken by the customer. The customers were instructed to make a decision if XVI or MOSAIQ does the corrective table movement; configure and ensure that the system only uses RATM or CMA for the corrective table movement, when in SYNERGISTIQ mode, and complete and return the IMPORTANT NOTICE Confirmation of Receipt form via fax at +44(0)1293 654401.
If you have any questions contact your local service representative at +44(0)1293 654200.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Syringe, piston - Product Code FMF
Causa
Small holes in the packaging may render the product non-sterile.
Acción
Merit Medical sent an Urgent Product Recall Notice dated September 9, 2010, to all sales representatives. The notice identified the product, the problem, and the action to be taken by the sales representatives and their customers. Sales representatives were instructed to contact all customers via telephone and instruct them to immediately discontinue use and quarantine any unused product.
Recall Notification Forms were to be completed and signed by the site representative and the customer and faxed to Merit customer service at 801-208-3378.
If customers were returning affected products they were to place the completed original Recall Notification Form in the box with the products to be returned, write the RGA# on the shipping box and return by Federal Express 2nd Day air to:
RGA Department
Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095-2416
For any questions regarding this recall call 801-316-4822 or 801-208-4365.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Syringe, piston - Product Code FMF
Causa
Small holes in the packaging may render the product non-sterile.
Acción
Merit Medical sent an Urgent Product Recall Notice dated September 9, 2010, to all sales representatives. The notice identified the product, the problem, and the action to be taken by the sales representatives and their customers. Sales representatives were instructed to contact all customers via telephone and instruct them to immediately discontinue use and quarantine any unused product.
Recall Notification Forms were to be completed and signed by the site representative and the customer and faxed to Merit customer service at 801-208-3378.
If customers were returning affected products they were to place the completed original Recall Notification Form in the box with the products to be returned, write the RGA# on the shipping box and return by Federal Express 2nd Day air to:
RGA Department
Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095-2416
For any questions regarding this recall call 801-316-4822 or 801-208-4365.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Syringe, piston - Product Code FMF
Causa
Small holes in the packaging may render the product non-sterile.
Acción
Merit Medical sent an Urgent Product Recall Notice dated September 9, 2010, to all sales representatives. The notice identified the product, the problem, and the action to be taken by the sales representatives and their customers. Sales representatives were instructed to contact all customers via telephone and instruct them to immediately discontinue use and quarantine any unused product.
Recall Notification Forms were to be completed and signed by the site representative and the customer and faxed to Merit customer service at 801-208-3378.
If customers were returning affected products they were to place the completed original Recall Notification Form in the box with the products to be returned, write the RGA# on the shipping box and return by Federal Express 2nd Day air to:
RGA Department
Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095-2416
For any questions regarding this recall call 801-316-4822 or 801-208-4365.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Syringe, piston - Product Code FMF
Causa
Small holes in the packaging may render the product non-sterile.
Acción
Merit Medical sent an Urgent Product Recall Notice dated September 9, 2010, to all sales representatives. The notice identified the product, the problem, and the action to be taken by the sales representatives and their customers. Sales representatives were instructed to contact all customers via telephone and instruct them to immediately discontinue use and quarantine any unused product.
Recall Notification Forms were to be completed and signed by the site representative and the customer and faxed to Merit customer service at 801-208-3378.
If customers were returning affected products they were to place the completed original Recall Notification Form in the box with the products to be returned, write the RGA# on the shipping box and return by Federal Express 2nd Day air to:
RGA Department
Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095-2416
For any questions regarding this recall call 801-316-4822 or 801-208-4365.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
I-stat analyzers batteries may overheat due to a circuitry failure, resulting in the analyzer becoming uncomfortably hot in the area of the battery component.
Acción
Abbott Point of Care issued Urgent Recall Notice letters dated September 20, 2010 to customers. The letter informs users to of the possibility of the unit becoming hot to touch, to remove the unit if this is the case, not to remove batteries unless instructed to do by APOC and to forward notification of the recall to customers if it has been further distributed.
Abbott Point of Care can be contacted at 800 366-8020, option 1, about this action.
Recall extended in May 2011 to included distribution dates of 9/20/2010-6/6/2011.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Syringe, piston - Product Code FMF
Causa
Small holes in the packaging may render the product non-sterile.
Acción
Merit Medical sent an Urgent Product Recall Notice dated September 9, 2010, to all sales representatives. The notice identified the product, the problem, and the action to be taken by the sales representatives and their customers. Sales representatives were instructed to contact all customers via telephone and instruct them to immediately discontinue use and quarantine any unused product.
Recall Notification Forms were to be completed and signed by the site representative and the customer and faxed to Merit customer service at 801-208-3378.
If customers were returning affected products they were to place the completed original Recall Notification Form in the box with the products to be returned, write the RGA# on the shipping box and return by Federal Express 2nd Day air to:
RGA Department
Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095-2416
For any questions regarding this recall call 801-316-4822 or 801-208-4365.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Calibrators, drug specific - Product Code DLJ
Causa
The assay may produce falsely elevated vancomycin results. inaccurate test results may result in inappropriate patient treatment.
Acción
Abbott Laboratories issued a Product Correction letters dated September 13 and 15, 2010 to all customers that received ARCHITECT iVancomycin reagents in the last 12 months. In the September 13, 2010 letter, the accounts were informed of the falsely elevated results and were instructed to continue to follow all sample handling instruction in the package insert and to take the following additional actions to mitigate the risk of obtaining an incorrect result:
1. After following the primary tube manufacturer's recommended centrifugation instructions transfer serum or plasma for all specimens to a microcentrifuge tube for centrifugation at 150,000-300,000 g-minutes, following centrifugation guidelines in the chart in the letter.
2. Prior to testing, transfer the serum or plasma to a sample cup or secondary tube for testing. Care must be taken to transfer only the clarified specimen and not the lipemic material or pellet.
The accounts were also requested to complete and fax back to Abbott the enclosed customer reply sheet, acknowledging the receipt and understanding of the recall.
On September 15, 2010, Abbott discovered that the calculation for the determination of RCF (xg) given in the September 13, 2010 letter was incorrect.
Incorrect Calculation previously provided:
Relative Centrifugal Force (RCF) = 0.0000118 x rotational radius in centimeters x RPM2
Correct Calculation within revised letter:
Relative Centrifugal Force (RCF) = 0.00001118 x rotational radius in centimeters x RPM2
Abbott stopped distribution of the previous letter and initiated redistribution of the revised letter to all impacted customers, globally, on September 15, 2010. Additionally, all customers which had already received the initial letter were sent a cover letter identifying the error.
Customers can contact Abbott at 1-877-422688 about this action.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Syringe, piston - Product Code FMF
Causa
Small holes in the packaging may render the product non-sterile.
Acción
Merit Medical sent an Urgent Product Recall Notice dated September 9, 2010, to all sales representatives. The notice identified the product, the problem, and the action to be taken by the sales representatives and their customers. Sales representatives were instructed to contact all customers via telephone and instruct them to immediately discontinue use and quarantine any unused product.
Recall Notification Forms were to be completed and signed by the site representative and the customer and faxed to Merit customer service at 801-208-3378.
If customers were returning affected products they were to place the completed original Recall Notification Form in the box with the products to be returned, write the RGA# on the shipping box and return by Federal Express 2nd Day air to:
RGA Department
Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095-2416
For any questions regarding this recall call 801-316-4822 or 801-208-4365.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Amended reason for recall: the piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for e. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for k. pneumoniae.
Acción
bioMerieux issued a "Product Correction Notice" letter dated September 13, 2010, to their entire customer base (regardless of whether they ever ordered the recalled cards). The letters explained the reason for the recall and instructed the account to confirm all results for E. coli using a second method, and for K. pneumoniae, to confirm with a second method only for resistant results. These alternate test confirmations are to continue until further notice. The customers were to complete and return the enclosed Acknowledgement Form via fax at (314) 731-8689 or (919) 620-6350 which indicate that the notice has been read, the instructions provided in the "Actions Required" section were followed, and notes if they have received any reports of illness or injury related to this issue. All future shipments will include an orange multilanguage insert to go into the boxes reminding customers they must perform an alternate test for TZP/E. coli combinations and that customers must also perform an alternate method prior to reporting TZP results when a resistant result is obtained for the TZP/K. pneumoniae. Additionally, this recall letter will accompany shipments of instrument software kits for the new customers.
The recalling firm issued a press release on 10/27/10 via the Associated Press notifying the public of the recall.
The recalling firm expanded their recall to add 7 more organisms to the list of organism testing that were to be suppressed. As a result the recalling firm issued a letter dated 3/30/11 via Fed Ex on 4/4/11 flagged "URGENT PRODUCT CORRECTION NOTICE (EXPANDED RECALL), VITEK 2 Piperacillin/Tazobactam Test, Document #9300786." The letter describes the issues, how the issues impact the test results, describes the product changes that are going to take place, and provides instructions on required actions to be taken.
The product changes will involve the eventual changeover to new cards that will be created which do not contain Piperacillin/Taz
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Assay, glycosylated hemoglobin - Product Code LCP
Causa
Test cartridges may leak and have the potential to generate error messages and biased inaccurate results.
Acción
BIO-RAD Laboratories Deeside sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated September 7, 2010, via registered mail to all subsidiaries/customers. The letter described the product, problem and actions to be taken by the customer. The customers were instructed to stop using and discard the test cartridges from the listed lots; complete and return the attached CUSTOMER MEDICAL DEVICE CORRECTION RESPONSE FORM via fax +44 1244 833401; record the number of affected kits of product, confirm that they have discarded the cartridges and record the method of disposal.
If you have any questions, contact +44 1244 288888.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Incorrect programming causes quickprint to fail to recognize the communication cradles. as a result, scanpoint communications cradles could not communicate with scanpoint online tool while using the quickprint interface. this will affect the transfer of exams and device calibration through quickprint interface.
Acción
On 09/20/10, Verathon issued an URGENT: Medical Device Accessory Recall Notification letter dated September 20, 2010 to consignees, identifying the affected product, the issue prompting the recall, and actions to be taken by consignees.
The consignees are instructed to return any cradles within the serial number range between CC012000-CC012084, and the Part Number 0570-0168.
The firm will provide a replacement communication cradle at no cost. Consignees can contact Verathon Customer Care at 425-867-1348 or 800-2331-2313 or send e-mail to cservice@verathon.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
One of the two connector ends of the medium cross connector may not be fully secured to the rod after tightening. this may not be readily apparent to the operating surgeon, resulting in inadequate torsional stability.
Acción
Biomet Spine issued an Urgent Medical Device Recall letter dated September 16, 2010 to distributors and physicians, identifying the affected device and actions to be taken.
Customers and distributors were requested to identify, remove, and immediately return the affected product to Biomet, following enclosed Product Return Instructions, and complete and return the Removal Tracking and Verification Form.
Customers and distributors can contact Biomet at 1-800-526-2579.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Device, vein stabilization - Product Code LBJ
Causa
The removable paper liner covering the adhesive strip that is used to secure the catheter stabilization device to the patient is pyrogenic. the device is labeled as nonpyrogenic.
Acción
Baxter issued Urgent Product Recall letters dated September 17, 2010 to the affected direct accounts. The accounts were informed that the paper lining covering the adhesive strip that is used to secure the catheter stabilization device to the patient was found to be pyrogenic. The accounts were requested to discontinue use and segregate the affected lots of products from inventory and call Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, 7:00 AM to 6:00 PM CT, to arrange for the return of the affected product for credit. The accounts were also requested to complete and fax back to Baxter the enclosed reply sheet confirming receipt of the letter and the amount of each product being returned. If the accounts further distributed the products, they were requested to forward the communication to those accounts.
Clinical questions regarding the communication are directed to the Medical Information Services at Baxter at 1-800-933-0303. Any other questions may be directed to the Center for One Baxter at 1-800-422-9837.