Device product
MEDLINE Sterile* Needle Counter, 100Ct. Double Magnet / Foam Block, reorder: DYNJNC100F 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-1931-2018
Product summary
- Event
- Event 80017
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14208 units
- Official record key
device-enforcement:Z-1931-2018
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: 67016114502, 67017014501, 67017024503, 67017034501, 67017044504, 67017054501, 67017054504, 67017064503, 67017074501, 67017074502, 67017084502, 67017094501, 67017104501, 67017114501
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.