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
Urological Catheter - Product Code KOD
Causa
Rochester medical observed some magic3 and hydrosil(r) catheter packages in which the catheter was caught in the package seal during the packaging process.
Acción
Consignees were contacted by telephone or in-person visit. The communication provided the reason for the recall and a list of affected products and their lot numbers, and instruction for the removal. Distributors were given instructions to notify their customers in turn.
For the customers that were not reached via telephone call or in-person, a letter, "Voluntary recall of magic product samples," was used for the recipients of product samples and sent via e-mail. The letter was dated January 14, 2009 and asked customers to destroy all of their remaining sample inventory of the affected lot numbers.
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
Urological Catheter - Product Code KOD
Causa
Rochester medical observed some magic3 and hydrosil(r) catheter packages in which the catheter was caught in the package seal during the packaging process.
Acción
Consignees were contacted by telephone or in-person visit. The communication provided the reason for the recall and a list of affected products and their lot numbers, and instruction for the removal. Distributors were given instructions to notify their customers in turn.
For the customers that were not reached via telephone call or in-person, a letter, "Voluntary recall of magic product samples," was used for the recipients of product samples and sent via e-mail. The letter was dated January 14, 2009 and asked customers to destroy all of their remaining sample inventory of the affected lot numbers.
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
Urological Catheter - Product Code KOD
Causa
Rochester medical observed some magic3 and hydrosil(r) catheter packages in which the catheter was caught in the package seal during the packaging process.
Acción
Consignees were contacted by telephone or in-person visit. The communication provided the reason for the recall and a list of affected products and their lot numbers, and instruction for the removal. Distributors were given instructions to notify their customers in turn.
For the customers that were not reached via telephone call or in-person, a letter, "Voluntary recall of magic product samples," was used for the recipients of product samples and sent via e-mail. The letter was dated January 14, 2009 and asked customers to destroy all of their remaining sample inventory of the affected lot numbers.
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
Urological Catheter - Product Code KOD
Causa
Rochester medical observed some magic3 and hydrosil(r) catheter packages in which the catheter was caught in the package seal during the packaging process.
Acción
Consignees were contacted by telephone or in-person visit. The communication provided the reason for the recall and a list of affected products and their lot numbers, and instruction for the removal. Distributors were given instructions to notify their customers in turn.
For the customers that were not reached via telephone call or in-person, a letter, "Voluntary recall of magic product samples," was used for the recipients of product samples and sent via e-mail. The letter was dated January 14, 2009 and asked customers to destroy all of their remaining sample inventory of the affected lot numbers.
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
Urological Catheter - Product Code KOD
Causa
Rochester medical observed some magic3 and hydrosil(r) catheter packages in which the catheter was caught in the package seal during the packaging process.
Acción
Consignees were contacted by telephone or in-person visit. The communication provided the reason for the recall and a list of affected products and their lot numbers, and instruction for the removal. Distributors were given instructions to notify their customers in turn.
For the customers that were not reached via telephone call or in-person, a letter, "Voluntary recall of magic product samples," was used for the recipients of product samples and sent via e-mail. The letter was dated January 14, 2009 and asked customers to destroy all of their remaining sample inventory of the affected lot numbers.
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
Set, I.V. Fluid Transfer - Product Code LHI
Causa
Stress crack on the stopcock.
Acción
The recalling firm issued letters dated 9/20/05 to the hospitals and sales representative informing them of the problem and the need to return the product.
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
Urological Catheter - Product Code KOD
Causa
Rochester medical observed some magic3 and hydrosil(r) catheter packages in which the catheter was caught in the package seal during the packaging process.
Acción
Consignees were contacted by telephone or in-person visit. The communication provided the reason for the recall and a list of affected products and their lot numbers, and instruction for the removal. Distributors were given instructions to notify their customers in turn.
For the customers that were not reached via telephone call or in-person, a letter, "Voluntary recall of magic product samples," was used for the recipients of product samples and sent via e-mail. The letter was dated January 14, 2009 and asked customers to destroy all of their remaining sample inventory of the affected lot numbers.
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
spinal bone tamp - Product Code HRX
Causa
Product not sterile: 10 units were released for distribution without undergoing sterilization process.
Acción
Sales representatives were contacted via e-mail on February 4, 2009, and instructed to contact hospitals and inform them of the issue and sequester affected product. They were further instructed to immediately travel to the hospitals and obtain affected product for return to Medtronic LLC. A Customer Communication Notice URGENT NOTICE: DEVICE REMOVAL dated February 9, 2009, was sent to the two consignees.
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, pipetting and diluting, for clinical use - Product Code JQW
Causa
To prevent a needle stick while replacing the probe, the firm has initiated a field correction, and issued an improved users guide procedure (user bulletin, part number 645050).
Acción
The firm, BD Biosciences, sent an information letter dated December 2008 with an enclosed New Probe Replacement Service/User Bulletin, to the customers. The letter described the product, problem and action to be taken. The customers were instructed to review the attached User Bulletin (Part Number 645050); ensure that their laboratory follows the updated procedure for removing and replacing probe; place the User Bulletin in their BD FACS SPA or SPA II User's Guide; always follow the instructions in User Bulletin to properly remove and replace probe, and complete and return the Effectivity Form via fax to 408-577-1409.
Should you have any comments or questions, please contact BD Biosciences at 1-877-232-8995 in the US. Outside the US, contact your regional BD office or field service engineer for assistance.
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
Counter, differential cell - Product Code GKZ
Causa
Burn risk-- when power is cycled to the instrument, there is a possibility that the mixer motor assembly may reach 100 degrees celsius (212 degrees fahrenheit ). if the customer touches the motor, burns may occur.
Acción
A "Product Correction" letter dated February 12, 2009 and "Customer Reply" form were sent to all currently active CELL-DYN Ruby customers using Software Version 2.0 ML. The letter described the affected product, necessary actions and contact information for customers. Customers were instructed to acknowledge receipt of the "Product Correction" letter by completing the enclosed Customer Reply form and return via fax to 1-800-777-0051.
A product information letter is being added to the accessory kits shipped with new instruments and version 2.0 ML System Software upgrade kits. For questions regarding this information, contact Abbott Laboratories Customer Support by calling 1-877-422-2688. Customers outside the US, please contact your local hematology customer support 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
Urological Catheter - Product Code KOD
Causa
Rochester medical observed some magic3 and hydrosil(r) catheter packages in which the catheter was caught in the package seal during the packaging process.
Acción
Consignees were contacted by telephone or in-person visit. The communication provided the reason for the recall and a list of affected products and their lot numbers, and instruction for the removal. Distributors were given instructions to notify their customers in turn.
For the customers that were not reached via telephone call or in-person, a letter, "Voluntary recall of magic product samples," was used for the recipients of product samples and sent via e-mail. The letter was dated January 14, 2009 and asked customers to destroy all of their remaining sample inventory of the affected lot numbers.
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
Urological Catheter - Product Code KOD
Causa
Rochester medical observed some magic3 and hydrosil(r) catheter packages in which the catheter was caught in the package seal during the packaging process.
Acción
Consignees were contacted by telephone or in-person visit. The communication provided the reason for the recall and a list of affected products and their lot numbers, and instruction for the removal. Distributors were given instructions to notify their customers in turn.
For the customers that were not reached via telephone call or in-person, a letter, "Voluntary recall of magic product samples," was used for the recipients of product samples and sent via e-mail. The letter was dated January 14, 2009 and asked customers to destroy all of their remaining sample inventory of the affected lot numbers.
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
Urological Catheter - Product Code KOD
Causa
Rochester medical observed some magic3 and hydrosil(r) catheter packages in which the catheter was caught in the package seal during the packaging process.
Acción
Consignees were contacted by telephone or in-person visit. The communication provided the reason for the recall and a list of affected products and their lot numbers, and instruction for the removal. Distributors were given instructions to notify their customers in turn.
For the customers that were not reached via telephone call or in-person, a letter, "Voluntary recall of magic product samples," was used for the recipients of product samples and sent via e-mail. The letter was dated January 14, 2009 and asked customers to destroy all of their remaining sample inventory of the affected lot numbers.
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
Urological Catheter - Product Code KOD
Causa
Rochester medical observed some magic3 and hydrosil(r) catheter packages in which the catheter was caught in the package seal during the packaging process.
Acción
Consignees were contacted by telephone or in-person visit. The communication provided the reason for the recall and a list of affected products and their lot numbers, and instruction for the removal. Distributors were given instructions to notify their customers in turn.
For the customers that were not reached via telephone call or in-person, a letter, "Voluntary recall of magic product samples," was used for the recipients of product samples and sent via e-mail. The letter was dated January 14, 2009 and asked customers to destroy all of their remaining sample inventory of the affected lot numbers.
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.
Equipment problem: i-stat cartridges were not properly sealed as the packaging system jammed, causing compromised seals.
Acción
Urgent Recall Notice letters pertaining to the EG7+ Cartridges were sent on February 23, 2009 by first class mail to all customers. The firm found one other affected lot of G3+ cartridges and expanded the recall to include one other lot. Letters for the expansion are dated May 2009. Customers were asked to use the attached form to record all of the box numbers if they have any cartridges from the affected lot. Cartridges from the box numbers listed will be replaced an any remaining unused cartridges from those specific boxes are to be returned as instructed on the form. To receive replacement cartridges, customers are to follow the instructions on the enclosed customer reply form. If any cartridges from the affected lot were forwarded to another facility, a copy of the recall letter needs to be provided to them and the information at the bottom of the customer reply form should be completed. Questions should be directed to 1-800-366-8020, Option 1.
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.
Instruction for use incorrect: there are no statements or warning on labels or instructions for use that 8, 9 and 10 mm diameter mrs cemented stems are indicated only for use in the gmrs proximal tibial and distal femoral components.
Acción
Urgent Product Recall letters, dated 1/30/2009, were sent to all Branches/agencies, Hospital Risk Management, Chief of Orthopaedics and Surgeons on January 30, 2009 via Federal Express. The letter asked consignees to examine their inventory and determine if they had any affected products, remove and quarantine affected product from their inventory, and complete the attached Product Recall Acknowledgment Form. The letter also stated that a Stryker Orthopaedics Sales representative would contact the consignee to reconcile and return the product . Consignees should contact their Stryker sales rep if they weren't not contacted by them. Questions should be directed to Colleen O'Meara at 201-831-5970.
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
Absorbable Polydioxanone Suture - Product Code NEW
Causa
Sterility issue: the firm decided to remove the product because it cannot assure the sterility of the products due to a failure in the sterilization process.
Acción
Urgent Voluntary Product Recall notification letters were sent via UPS Next Day Air with receipt on February 2, 2009. Letters were sent to customers, Directors of Surgical Services, Director of Risk Management, Materials Manager and Distributors. The letters requested that customers immediately discontinue use of the products with lot numbers listed. Customers are to identify and return only the boxes identified in the attached tables. The affected product should be returned to Ethicon via the pre-paid authorized shipping label. Customers that are not returning affected product should mail the enclosed business reply card to Ethicon. Customers should direct questions regarding this recall to 1-888-202-3694 or their Ethicon sales representative.
5/13/09: It was discovered that a lot of PDS II sutures that had been previously identified as affected but not distributed, were mistakenly distributed. Revised letters including this number were sent to 25 customers on 5/13/09.
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
Absorbable Polydioxanone Suture - Product Code NEW
Causa
Sterility issue: the firm decided to remove the product because it cannot assure the sterility of the products due to a failure in the sterilization process.
Acción
Urgent Voluntary Product Recall notification letters were sent via UPS Next Day Air with receipt on February 2, 2009. Letters were sent to customers, Directors of Surgical Services, Director of Risk Management, Materials Manager and Distributors. The letters requested that customers immediately discontinue use of the products with lot numbers listed. Customers are to identify and return only the boxes identified in the attached tables. The affected product should be returned to Ethicon via the pre-paid authorized shipping label. Customers that are not returning affected product should mail the enclosed business reply card to Ethicon. Customers should direct questions regarding this recall to 1-888-202-3694 or their Ethicon sales representative.
5/13/09: It was discovered that a lot of PDS II sutures that had been previously identified as affected but not distributed, were mistakenly distributed. Revised letters including this number were sent to 25 customers on 5/13/09.
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
knee prosthesis component - Product Code HSX
Causa
Smaller diameter screws than required were included in the package.
Acción
Zimmer notified consignees by recall letter dated 2/25/09 instructing them to cease use of the device and to return it. Zimmer distributors and international accounts were notified by email on 2/26/09.
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
Replacement Heart-Valve - Product Code DYE
Causa
Medtronic identified several heart valves (mosaic porcine bioprosthesis with cinch & hancock ii bioprosthesis with cinch) that were inadvertently distributed after exposure to temperatures exceeding the 77 f (25 c) maximum storage temperature published on the labeling. the product is being retrieved as they do not meet the handling requirements.
Acción
A Medtronic "Urgent Medical Device Recall Notice" dated January 26, 2009, was sent to Risk Managers of each affected account and to each Implanting Physician. The letter described the problem, product and informed consignees that they will be retrieving the non-implanted vales. If additional information is needed, customers are to contact their local Medtronic sales representative or technical services at 1-877-526-7890.
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
Replacement Heart-Valve - Product Code DYE
Causa
Medtronic identified several heart valves (mosaic porcine bioprosthesis with cinch & hancock ii bioprosthesis with cinch) that were inadvertently distributed after exposure to temperatures exceeding the 77 f (25 c) maximum storage temperature published on the labeling. the product is being retrieved as they do not meet the handling requirements.
Acción
A Medtronic "Urgent Medical Device Recall Notice" dated January 26, 2009, was sent to Risk Managers of each affected account and to each Implanting Physician. The letter described the problem, product and informed consignees that they will be retrieving the non-implanted vales. If additional information is needed, customers are to contact their local Medtronic sales representative or technical services at 1-877-526-7890.
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.
Please be aware that this is not a new recall. the firm has taken action; but, due to administrative issues this recall is now being classified by the agency. the vertical lift column power supply in the mainframe c-arm of the device is defective and subject to early life failure.
Acción
Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. The firm, GE Healthcare, Surgery, sent an "URGENT RECALL NOTICE" dated November 8, 2006 via certified mail with return receipt request to consignees/customers with specific instructions. Customers were advised "to stop using the system WITH NAVIGATION until this replacement has been successfully completed. OEC@ FluoroTrak 9800 Plus system may be used as a standard C-Arm providing you review the other issues as listed below." GEHC OEC is actively working on solutions that will permanently resolve each of the noted issues.
If you have any questions or concerns regarding these issues, please do not hesitate to contact the service team for further information at 800-874-7378 option 8. Information is available at this number 24 hours per day, 7 days a week.
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
Wheeled Hospital Stretcher - Product Code FPO
Causa
The head section backrest (fowler) may not raise up, or, if up, may drop suddenly due to wearing out of the actuator threads on the fowler.
Acción
Consignees were notified by an Urgent - Medical Device Correction letter dated 2/27/09, advised of the problem and instructed to locate stretchers and verify that there is no grinding noise when activating the fowler electrically. Consignees were also instructed to remove any stretchers with a fowler that was non-operational, or which makes a grinding sound, from service until the firm makes repairs and contact the firm. Stretchers will be corrected within the next four months by a Stryker field service representative. The enclosed post card should be returned to confirm receipt of the notification. The notice should be forwarded to any users that have borrowed or purchased the stretchers and the firm should be notified of their new location. Also, if any of the affected stretchers have been disposed of or are no longer in use, the firm needs to be provided with their serial numbers. Questions or concerns should be directed to Andrea Kuthe at 269-324-6581.
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
Wheeled Hospital Stretcher - Product Code FPO
Causa
The head section backrest (fowler) may not raise up, or, if up, may drop suddenly due to wearing out of the actuator threads on the fowler.
Acción
Consignees were notified by an Urgent - Medical Device Correction letter dated 2/27/09, advised of the problem and instructed to locate stretchers and verify that there is no grinding noise when activating the fowler electrically. Consignees were also instructed to remove any stretchers with a fowler that was non-operational, or which makes a grinding sound, from service until the firm makes repairs and contact the firm. Stretchers will be corrected within the next four months by a Stryker field service representative. The enclosed post card should be returned to confirm receipt of the notification. The notice should be forwarded to any users that have borrowed or purchased the stretchers and the firm should be notified of their new location. Also, if any of the affected stretchers have been disposed of or are no longer in use, the firm needs to be provided with their serial numbers. Questions or concerns should be directed to Andrea Kuthe at 269-324-6581.
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
Thermal regulating system - Product Code DWJ
Causa
The blower on the warmair 135 warming unit may overheat. resistance in a connector between circuit board and wiring harness results in excessive heat that may melt connector or deform the outer casing of the blower unit.
Acción
The firm sent an "URGENT Medical Device Recall' notice via First Class Mail on 2/16/2009 (Note: the letter is dated 2/13/2009). The notice informs the customers of the potential for the device to overheat and of the 'small number of customer complaints received by CSZ concerning this issue. In addition, the notice asks that the customers inspect their units for signs of discoloration indicative of a faulty connector. In the notice, the customers were instructed to return the product to CSZ for repair by contacting their Customer Service division and obtaining a Return Authorization number and specific instructions concerning packaging and returning of the unit(s) for repair. The customer is also instructed to complete the attached Recall Response Form which accompanies the recall notification. The notification provides that customer with a toll-free number at (800) 989-7373ext.3234 or call collect at (513) 719-3234 to reach CSZ representative between the hours of 8:30 a.m. until 4:30 P.M. Monday through Friday EST. Once the customer ships the recalled unit to CSZ, the firm will repair the unit(s) using new connectors manufactured, after which time, the repaired unit is returned to distribution for customer use.