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
Glucose dehydrogenase, glucose - Product Code LFR
Causa
All 10- or 25- count glucose test strip vials, either loose vials or found in patient starter kits of contour, contour ts and contour" usb blood glucose meters are being recalled a packaging issue which, under certain conditions, can cause some test strips packaged in some small-count vials to operate outside of us fda-cleared performance specifications and produce a low-bias reading during blood.
Acción
Bayer sent an "URGENT DIABETES TEST STRIP RECALL" letter dated August 12, 2011, to its customers with the name of the test strips, sizes recalled, reason for the recall, potential injury, and instructions to discontinue use and return the test strips to Bayer. The recall letter also included a recall response form that was to be faxed back to Bayer at 1-800-876-2243. For questions call Customer Logistics at 1-800-348-2637.
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 recall was expanded because between february and april 2011, biosense webster, inc. notified customers that a voluntary customer notification had been initiated due to the inaccessibility of the electronic version of the instructions for use (e-ifu) for the "10 ft. interface cable, 10 pin - shielded tip pins to 12 pin - blue", catalog number d128709,
through the j&j; gateway (i.E., e-ifu websi.
Acción
Biosense Webster sent an "URGENT FIELD SAFETY NOTICE" letter dated April 29, 2011 to all affected customers. The letter describes the product, problem, and the action taken by the firm.
The letter notifies and advises customers that the updated IFUs for ISMUS Catheter with Auto ID Technology and the Duo-Decapolar catheters have been released and posted on the e-IFU website as of April 22, 2011 and April 21, 2011. Customers were instructed to complete the Acknowledgement Form and return the form to Biosense.
Customers with questions or require additionial information were instructed to contact their Biosense Webster 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.
Notas adicionales en la data
Catheter, electroderecording, or probe, electrode recording - Product Code DRF
Causa
The recall was expanded because between february and april 2011, biosense webster, inc. notified customers that a voluntary customer notification had been initiated due to the inaccessibility of the electronic version of the instructions for use (e-ifu) for the "10 ft. interface cable, 10 pin - shielded tip pins to 12 pin - blue", catalog number 0128709,
through the j&j; gateway (i.E., e-ifu websi.
Acción
Biosense Webster sent an "URGENT FIELD SAFETY NOTICE" letter dated April 29, 2011 to all affected customers. The letter describes the product, problem, and the action taken by the firm.
The letter notifies and advises customers that the updated IFUs for ISMUS Catheter with Auto ID Technology and the Duo-Decapolar catheters have been released and posted on the e-IFU website as of April 22, 2011 and April 21, 2011. Customers were instructed to complete the Acknowledgement Form and return the form to Biosense.
Customers with questions or require additionial information were instructed to contact their Biosense Webster 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.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Notas adicionales en la data
Pump, infusion - Product Code FRN
Causa
Hospira has received reports of sparking, smoking, charring and electrical shock when using the gemstar docking station due to fluid ingress into the docking station.
Acción
Hospira Inc. sent an "URGENT DEVICE FIELD CORRECTION" letter dated August 1, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.
The requests that customers do not hang or place fluid containers over the docking station, not spray fluid directly on the docking station, and to clean the docking station using a cloth dampened with an apporoved cleaning solution. A reply form was attached to the letter for customers to complete and return via fax at 262-577-6921.
Contact Hospira at 1-800-441-4100 for questions concerning this notice.
*** Hospira sent an update letter dated September 26, 2012 to the accounts, informing them of the availability of the improved design replacement docking stations, and requesting them to complete and return the enclosed reply via fax or e-mail to Hospira, indicating the number of docking stations to be returned for replacement at no charge if the old docking stations are returned within 45 days of receipt of the replacement stations. ***
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.
Plastic needle tip could possibly crack or separate.
Acción
Varian Medical Systems sent a "CUSTOMER TECHNICAL BULLETIN" letter dated September 30, 2008 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter instructed users to inspect needle tips before and after every clinical application to prevent needle tip separation or cracking.
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
sterilizer, chemical - Product Code MLR
Causa
Steris learned that amsco¿ v-pro 1 and v-pro 1 plus low temperature sterilization systems users may experience premature wear of the vacuum pump and filtering assembly components. users may also experience incomplete aeration of the device's chamber following a failed leak test.
Acción
Steris Corporation sent an URGENT VOLUNTARY FIELD CORRECTION NOTICE dated August 5, 2011, to all affected customers.The letter identified the product the problem and the action needed to be taken by the customer.
A STERIS Service Representative will contact your facility to arrange for STERIS to upgrade your V-PRO System(s). You can continue to use your system prior to the installation of the system upgrades. In the interim period should you experience any alarms or aborted cycles, the load must
be handled in accordance with the Amsco¿ V-PROTM 1 and V-PROTM 1Plus Low Temperature Sterilization Systems Operators Manual and your internal hospital procedures.
For further information or if you have questions regarding this matter, please contact Field Service Dispatch at 1-800-333-8828.
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 affected lots of stromatolyser-im lysing reagent were found to be contaminated with pseudomonas bacteria, which resulted in rising imi channel background counts, increased false "platelet clump" flags and a strong sulfur-like odor when used on the xe-2100, xe-2100l and xe-5000 analyzers.
Acción
Sysmex America, Inc. sent a "PRODUCT NOTIFICATION" letter dated April 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken.
The letter instructs customers to discontinue use of the affected SIM lots, and to remove affected lots from their analyzers as soon as possible to avoid long-term performance problems on the analyzer. A Stromatolyser -IM (220-A) Voluntary Recall form was attached for customers to complete and return via fax to Sysmex Customer Service at 800-689-8296. The form will be used to place orders to replace the affected product.
Any questions concerning the information contained in the notification are directed to the Sysmex Technical Assistance Center at 1-888-879-7639.
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
Introducer Catheter. - Product Code DYB
Causa
The product may contain an incorrect size catheter and introducer.
Acción
AngioDynamics, Inc contacted affected customers initially via telephone and a follow up "Notification of Medical Device Correction" letter was sent dated August 1, 2011.
The letter informed them of the problem and provided instructions. Customers were instructed to utilize the 8F Introducer Sheath provided within the 8F Smart Port CT Implantable Port during port implantation. The 8F Valved Sheath (V18) may continue to be utilized during the placement of the 7.5F Smart Port Implantable Port (for example: CT75STSD; CT75STSD-NF).
For question on this recall contact AngioDynamics, Inc at (800) 772-6446.
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
Implantable Port - Product Code DYB
Causa
The product may contain an incorrect size catheter and introducer.
Acción
AngioDynamics, Inc contacted affected customers initially via telephone and a follow up "Notification of Medical Device Correction" letter was sent dated August 1, 2011.
The letter informed them of the problem and provided instructions. Customers were instructed to utilize the 8F Introducer Sheath provided within the 8F Smart Port CT Implantable Port during port implantation. The 8F Valved Sheath (V18) may continue to be utilized during the placement of the 7.5F Smart Port Implantable Port (for example: CT75STSD; CT75STSD-NF).
For question on this recall contact AngioDynamics, Inc at (800) 772-6446.
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
Radiological Image Processing System - Product Code LLZ
Causa
Ge healthcare has become aware that image orientation of reference series displayed in functool diffusion tensor/fibertrak protocol on advantage workstation may not match with the orientation annotations displayed in the viewport. this issue may impact patient safety.
Acción
GE Healthcare sent "Urgent Medical Device Correction" letters dated August 18, 2011 to all affected customers.
The letter included name of product affected and described problem. Recommended actions where provided to customers and they were notified a GE Healthcare representative will contact them for a software system upgrade.
For question of this recall contact the GE Service Representative at (800) 437-1171.
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
Station, pipeting and diluting for clinical use - Product Code JQW
Causa
The recall was initiated because beckman coulter has confirmed an issue with the coulter preplus 2. the reagent level sensing is impaired and will give no warning when a reagent vial is low or out of reagent. due to the size difference in the vertical mounts, the reagent rack is not aligned optimally for the probe to aspirate or level sense the antibody. this misalignment yields impaired reagen.
Acción
Beckman Coulter initiated an URGENT: PRODUCT CORRECTIVE ACTION (PCA) letter dated August 24, 2010, with attached PCA Response Form to all affected customers who purchased the Coulter PrepPlus 2. The letter provided the customers with an explanation of the problem identified and an action to be taken. The customers were instructed to not use the PrepPlus2 until their Beckman Coulter representative corrects the problem. A review of all results generated from samples prepared from the system should be conducted. Any unexpected dim fluorescence and/or decreased number stained cells should be evaluated for re-analysis, including preparing a new sample. Customers were also instructed to complete and return the enclosed response form within 10 days.
Customers with any questions regarding this PCA, were instructed to call Beckman Coulter Customer service at (800) 526-7694. Outside of USA, customers were instructed to contact their local Beckman Coulter 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.
Notas adicionales en la data
Lift, patient, non ac-powered - Product Code FSA
Causa
The entroy pool lift boom may rapidly lower un-commanded to the bottom of its stroke, with a potential for injury to the resident or caregiver.
Acción
ArjoHuntleigh sent an Urgent Field Correction Notice I.D. 110701AHE to the affected end user via UPS 2nd Day on August 4, 2011. The notice informed the account of the potential for lift boom to rapidly lower un-commanded to the bottom of its stroke. The account was requested to immediately cease use of the affected lift, and disconnect the power to the lift to prevent further use until corrected. The account was requested to complete and sign the Customer Response Form, and return it to ArjoHuntleigh to schedule a service call to correct the lift. Questions were directed to the ArjoHuntleigh at 1-800-323-1245, ext 54485.
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.
Blood lines coiling tabs #1 and #5 on the arterial line are not in the correct positions.
Acción
Fresenius Medical Care sent out an "Urgent" recall notice dated August 11, 2011 to all affected customers .
The letter included description of the product name, problem and asked them to examine their stock immediately and quarantine bloodlines from the recalled lots. Customers were asked to return the product to Fresenius.
For information on this recall call the Fresenius Customer Service Team at 1-800-323-5188.
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.
A limited number of model 6476, 6482, and 6468 (not available in the us) latitude communicators are unable to authenticate, and thus cannot connect to the latitude system. customers are instead receiving latitude temporarily unavailable (ltu) message.
Acción
Boston Scientific CRM Corporation sent a " Dear Patient", letter dated August 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
A new communicator is being shipped separately to you with a corrected security certificate that will allow it to be activated and function normally.
1. Please activate this new equipment at your convenience to begin home monitoring. Activation instructions are enclosed with the communicator.
2. We also ask that you return the original communicator previously delivered to you:
" Place the original equipment in the shipping box used for the new equipment.
" Pack newspaper or other filler around the equipment to prevent damage during shipping, and seal the box.
" Enter your address in the FROM section of the prepaid Federal Express label, and apply the return label to the outside of the box directly over the original label.
" Call Federal Express at 1.800.463.3339 to schedule a pick-up.
We apologize for this inconvenience. If you have further questions, please call 1.866.484.3268.
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
Wire, Guide, Catheter - Product Code DQX
Causa
Boston scientific is voluntarily recalling one lot/batch of katzen" infusion wires because we have identified that the label on the carton and the inner pouch indicated an incorrect device length. the labels indicate a device length of 180cm while the actual device length is 145cm.
Acción
Boston Scientific sent an "Urgent Medical Device Recall Removal" letter dated August 1, 2011 to all affected customers.
The letter described the problem and product being recalled and advised customers to segregate the affected product immediately and return it to Boston Scientific. Boston Scientific requested the completion and return of the Reply Verification Tracking Form.
For additional information on this recall call Boston Scientific Quality Systems at (763) 494-1133.
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 sterility has the potential to be compromised.
Acción
Encore Medical Lp sent a Urgent Field Safety Notice dated August 17, 2011. to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Customers were instructed to immediately quarantine these devices if you have not already done so. Contact Customer Service to obtain replacement devices as well as an RMA. Return all affected devices by October 31, 2011, using the RMA Customer Service provided in step #3.
If you have any further questions you may call (512 ) 834-6330. For International Customer Service please call (512) 834-6275.
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.
3-t medical systems one way vent valves, included in the custom terumo cardiovascular kits, may separate at the bond that holds the two halves.
Acción
Terumo Cardiovascular Systems initiated contact on August 12, 2011 by phone, fax, email and Urgent: Medical Device Recall mail to all affected customers.
The firm advised customers of the affected product, problem and required recall actions. Customers can remove whole customized packs that are not in urgent medical need and return packs. Or the User may opt to use a sterile LH 130 vent valve from Terumo Cardiovascular Systems. A response form was included to return back to the firm.
For questions on this recall contact Terumo Customer Service at (734) 525-9580.
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.
3-t medical systems one way vent valves, included in the custom terumo cardiovascular kits, may separate at the bond that holds the two halves.
Acción
Terumo Cardiovascular Systems initiated contact on August 12, 2011 by phone, fax, email and Urgent: Medical Device Recall mail to all affected customers.
The firm advised customers of the affected product, problem and required recall actions. Customers can remove whole customized packs that are not in urgent medical need and return packs. Or the User may opt to use a sterile LH 130 vent valve from Terumo Cardiovascular Systems. A response form was included to return back to the firm.
For questions on this recall contact Terumo Customer Service at (734) 525-9580.
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
Manual Radionuclide Applicator System - Product Code IWJ
Causa
Length of the cannula hub is longer and may not permit a fit with the applicator.
Acción
BrachySciences, a division of Biocompatibles, Inc., sent out "Urgent Recall Device Recall" letters Dated August 12, 2011 to all affected customers.
The letter included affected product and problem description. Customers are asked to quarantine and return unused product. A Product Recall & Retrieval Form was included to send back to the firm.
For questions on this recall contact the firm at (203) 262-0571, extension 105.
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.
3-t medical systems one way vent valves, included in the custom terumo cardiovascular kits, may separate at the bond that holds the two halves.
Acción
Terumo Cardiovascular Systems initiated contact on August 12, 2011 by phone, fax, email and Urgent: Medical Device Recall mail to all affected customers.
The firm advised customers of the affected product, problem and required recall actions. Customers can remove whole customized packs that are not in urgent medical need and return packs. Or the User may opt to use a sterile LH 130 vent valve from Terumo Cardiovascular Systems. A response form was included to return back to the firm.
For questions on this recall contact Terumo Customer Service at (734) 525-9580.
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.
3-t medical systems one way vent valves, included in the custom terumo cardiovascular kits, may separate at the bond that holds the two halves.
Acción
Terumo Cardiovascular Systems initiated contact on August 12, 2011 by phone, fax, email and Urgent: Medical Device Recall mail to all affected customers.
The firm advised customers of the affected product, problem and required recall actions. Customers can remove whole customized packs that are not in urgent medical need and return packs. Or the User may opt to use a sterile LH 130 vent valve from Terumo Cardiovascular Systems. A response form was included to return back to the firm.
For questions on this recall contact Terumo Customer Service at (734) 525-9580.
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.
Plastic needle tip could possibly crack or separate.
Acción
Varian Medical Systems sent a "CUSTOMER TECHNICAL BULLETIN" letter dated September 30, 2008 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter instructed users to inspect needle tips before and after every clinical application to prevent needle tip separation or cracking.
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.
3-t medical systems one way vent valves, included in the custom terumo cardiovascular kits, may separate at the bond that holds the two halves.
Acción
Terumo Cardiovascular Systems initiated contact on August 12, 2011 by phone, fax, email and Urgent: Medical Device Recall mail to all affected customers.
The firm advised customers of the affected product, problem and required recall actions. Customers can remove whole customized packs that are not in urgent medical need and return packs. Or the User may opt to use a sterile LH 130 vent valve from Terumo Cardiovascular Systems. A response form was included to return back to the firm.
For questions on this recall contact Terumo Customer Service at (734) 525-9580.
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.
3-t medical systems one way vent valves, included in the custom terumo cardiovascular kits, may separate at the bond that holds the two halves.
Acción
Terumo Cardiovascular Systems initiated contact on August 12, 2011 by phone, fax, email and Urgent: Medical Device Recall mail to all affected customers.
The firm advised customers of the affected product, problem and required recall actions. Customers can remove whole customized packs that are not in urgent medical need and return packs. Or the User may opt to use a sterile LH 130 vent valve from Terumo Cardiovascular Systems. A response form was included to return back to the firm.
For questions on this recall contact Terumo Customer Service at (734) 525-9580.
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.
3-t medical systems one way vent valves, included in the custom terumo cardiovascular kits, may separate at the bond that holds the two halves.
Acción
Terumo Cardiovascular Systems initiated contact on August 12, 2011 by phone, fax, email and Urgent: Medical Device Recall mail to all affected customers.
The firm advised customers of the affected product, problem and required recall actions. Customers can remove whole customized packs that are not in urgent medical need and return packs. Or the User may opt to use a sterile LH 130 vent valve from Terumo Cardiovascular Systems. A response form was included to return back to the firm.
For questions on this recall contact Terumo Customer Service at (734) 525-9580.