Recall Z-2472-2019
B. Braun Medical, Inc. · initiated July 10, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
CE18TKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339188
Codes / lots: Lot # 0061537846 Exp: 8/31/2018 Lot # 0061537847 Exp: 10/31/2018 Lot # 0061620282 Exp: 9/30/2019 UDI: 04046964941436
Reason for recall
The filter capacity is not achieved due to damage of the filter membrane.
FDA-determined cause: Under Investigation by firm
Action taken
1. Review the Device Recall Notification entirety and ensure that all users in your organization are informed about this voluntary product recall. If you are a distributor, please forward this recall notification to your customers. The recall is to be extended to the consumer level. 2. Determine your current inventory of the affected lots within your facility. Do not destroy any affected product. 3. Utilizing the attached, Product Removal Acknowledgement form, record the total number of individual units (within partial cases) and the number of full-unopened cases. If you have no inventory remaining, please enter zero (0) on the form. 4. Return the completed Product Removal Acknowledgement form to B. Braun Medical Inc. Quality Assurance department by faxing the form to (610) 849-1197 or e-mail to PA_QualityAssurance.BBMUS_Service@bbraunusa.com within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). 5. If you have any full cases, partial cases or unused individual pieces of these affected products as identified in the Product Removal Acknowledgement form that was submitted to BBMI Quality Assurance Department, a BBMI Customer Support Representative will contact you to provide instructions for handling the affected product and arrange for return to BBMI. This may include credit or replacement product. Should you identify product where this issue has occurred, please report the event promptly to BBMI by contacting our Clinical and Technical Support Department at 1-800-854-6851
Details
- Recall number
- Z-2472-2019
- Initiated
- July 10, 2019
- Terminated
- August 21, 2020
- Product code
- OFT – Spinal Epidural Anesthesia Kit
- Quantity
- 3820 units
- Distribution
- CA FL MO TX MN AL GA NC IL PA
- Recalling firm
- B. Braun Medical, Inc., Allentown, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2466-2019 Class II | ES1725KFXN ESPOCAN SPINAL/EPID TRY NRFIT Catalog # 339114The filter capacity is not achieved due to damage of the filter membrane. | 07/10/2019Terminated |
| Z-2467-2019 Class II | ES1827KN SPINAL/EPIDURAL TRAY NRFIT Catalog # 339115The filter capacity is not achieved due to damage of the filter membrane. | 07/10/2019Terminated |
| Z-2468-2019 Class II | FEF 100N FLAT EPIDURAL FILTER NRFIT Catalog # 339160The filter capacity is not achieved due to damage of the filter membrane. | 07/10/2019Terminated |
| Z-2469-2019 Class II | CE17TKN CONT EPIDURALTUOHY NRFIT Catalog # 339183The filter capacity is not achieved due to damage of the filter membrane. | 07/10/2019Terminated |
| Z-2470-2019 Class II | CE17TKFCN EPID TRAY W/ 17GA TUOHY NRFIT Catalog # 339186The filter capacity is not achieved due to damage of the filter membrane. | 07/10/2019Terminated |
| Z-2471-2019 Class II | CE17TKFCSN CON EPI TRAY W/17G TUHY NRFIT Catalog # 339187The filter capacity is not achieved due to damage of the filter membrane. | 07/10/2019Terminated |
| Z-2473-2019 Class II | CE18HKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339189The filter capacity is not achieved due to damage of the filter membrane. | 07/10/2019Terminated |
| Z-2474-2019 Class II | CE18TKSTN CONT EPID W/SOFT TIP NRFIT Catalog # 339191The filter capacity is not achieved due to damage of the filter membrane. | 07/10/2019Terminated |