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

Medline Industries Inc: MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 100 Ct. Double Magnet / Foam Block with Blade Remover, reorder: NC100FBR Product Usage: A needle counter is intended to be

Is my product affected?

MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 100 Ct. Double Magnet / Foam Block with Blade Remover, reorder: NC100FBR 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 co

  • UPC 67016114502
  • UPC 67016124501
  • UPC 67016124502
  • UPC 67016124507
  • UPC 67017014501
  • UPC 67017024502
  • UPC 67017034501
  • UPC 67017034503
  • UPC 67017064502
  • UPC 67017074502
  • UPC 67017084502
  • UPC 67017084503
  • UPC 67017094501
  • UPC 67017094503
  • UPC 67017094505
  • UPC 67017104501
  • UPC 67017114501
  • UPC 67017114502

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

What happened

Medline Industries Inc is recalling MEDLINE O.R. Necessities Sterile Needle Counter products (100 count with double magnet/foam block and blade remover, reorder number NC100FBR) due to a packaging defect. The product packaging seals may experience seal creep, which can create gaps in the seals and compromise the sterility of the needle counters. The recall affects 80,200 units distributed nationwide in the United States and internationally in Canada, Saudi Arabia, the Cayman Islands, and the United Arab Emirates. The affected lot numbers are 67016114502, 67016124501, 67016124502, 67016124507, 67017014501, 67017024502, 67017034501, 67017034503, 67017064502, 67017074502, 67017084502, 67017084503, 67017094501, 67017094503, 67017094505, 67017104501, 67017114501, and 67017114502.

The source document does not specify what actions affected consumers should take regarding this recall.

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: 80200 units Lot/code info: Lot Numbers: 67016114502 67016124501 67016124502 67016124507 67017014501 67017024502 67017034501 67017034503 67017064502 67017074502 67017084502 67017084503 67017094501 67017094503 67017094505 67017104501 67017114501 67017114502

Source

Official record: FDA (Device enforcement) ↗

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

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