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Recall Observatory FDA recall evidence

Device product

MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Magnet, reorder: DYNJNC40F 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-1933-2018

April 24, 2018

Class II

Product summary

Firm
Medline Industries Inc
Event
Event 80017
Status
Terminated
Classification
Class II
Quantity
220608 units
Official record key
device-enforcement:Z-1933-2018

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 67016124502 67016124503 67016124504 67017014501 67017024501 67017024502 67017024503 67017024504 67017034501 67017034503 67017044503 67017044504 67017044505 67017054501 67017054502 67017054503 67017054504 67017064501 67017064502 67017064503 67017064504 67017074501 67017074502 67017084501 67017084502 67017104501

Distribution pattern: Worldwide Distribution - US Nationwide and the countries of: Canada, Saudi Arabia, Cayman Island, and United Arab Emirates

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.