Device product
MEDLINE O.R. Necessities(R) STERILE R, Needle Counter/Compte-aiguiles/Caja de agujas, Gold Standard/Standard Or/Oro y Estander, 40 Ct. Foam Block / Magnet with Blade Remover, Coussinet en mousse pour 40 aiguilles /Magnetise avec quitte-lame Or, 40 Ct Bloque de espuma / Iman Con extractor de hoja - Oro, REF NC40FBRGS 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-1936-2018
Product summary
- Event
- Event 80017
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2600 units
- Official record key
device-enforcement:Z-1936-2018
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 67016124502 67017014501 67017024502 67017064502 67017064503 67017074501 67017074502 67017084502 67017084503 67017104501
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.