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FDA (Device enforcement)Recalled 2018-04-24closedclass ii

Medline Industries Inc: 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

Is my product affected?

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

  • UPC 67016114502
  • UPC 67017014501
  • UPC 67017024503
  • UPC 67017034501
  • UPC 67017044504
  • UPC 67017054501
  • UPC 67017054504
  • UPC 67017064503
  • UPC 67017074501
  • UPC 67017074502
  • UPC 67017084502
  • UPC 67017094501
  • UPC 67017104501
  • UPC 67017114501

Check against the official notice below — it lists the full affected range.

What happened

Medline Industries Inc. is recalling 14,208 units of MEDLINE Sterile Needle Counter, 100 Count (reorder number DYNJNC100F) due to a packaging defect. The product's packaging seal may experience seal creep, which can create gaps in the seals and compromise the sterility of the needle counters. The affected product was distributed nationwide in the United States and also in Canada, Saudi Arabia, the Cayman Islands, and the United Arab Emirates.

The recall affects 14 specific lot numbers: 67016114502, 67017014501, 67017024503, 67017034501, 67017044504, 67017054501, 67017054504, 67017064503, 67017074501, 67017074502, 67017084502, 67017094501, 67017104501, and 67017114501. The source document does not specify a remedy or what affected consumers should do.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide Distribution - US Nationwide and the countries of: Canada, Saudi Arabia, Cayman Island, and United Arab Emirates Quantity: 14208 units Lot/code info: Lot Numbers: 67016114502, 67017014501, 67017024503, 67017034501, 67017044504, 67017054501, 67017054504, 67017064503, 67017074501, 67017074502, 67017084502, 67017094501, 67017104501, 67017114501

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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