Device product
MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Adhesive, reorder: DYNJNC40A Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the surgical site or the patient.
Z-1932-2018
Product summary
- Event
- Event 80017
- Status
- Terminated
- Classification
- Class II
- Quantity
- 38464 units
- Official record key
device-enforcement:Z-1932-2018
Official wording
Reason: The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counters.
Code information: Lot Numbers: 67016114501 67016114502 67016114503 67016124501 67016124503 67016124504 67017024501 67017024502 67017024503 67017024504 67017034503 67017064503 67017084503 67017094501 67017094502 67017104501 67017104502
Distribution pattern: Worldwide Distribution - US Nationwide and the countries of: Canada, Saudi Arabia, Cayman Island, and United Arab Emirates
Derived failure modes
-
Unknown
The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counters.