Recalls / —
—#175367
Product
CE17TKFCN EPID TRAY W/ 17GA TUOHY NRFIT Catalog # 339186
- FDA product code
- OFT — Spinal Epidural Anesthesia Kit
- Device class
- Class 2
- Medical specialty
- Anesthesiology
- Affected lot / code info
- Lot # 0061536043 Exp: 8/31/2018 Lot # 0061620273 Exp:11/30/2019 UDI: 04046964941399
Why it was recalled
The filter capacity is not achieved due to damage of the filter membrane.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
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
Recalling firm
- Firm
- B. Braun Medical, Inc.
- Address
- 901 Marcon Blvd, Allentown, Pennsylvania 18109-9512
Distribution
- Distribution pattern
- CA FL MO TX MN AL GA NC IL PA
Timeline
- Recall initiated
- 2019-07-10
- Terminated
- 2020-08-21
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #175367. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.