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

Medline Industries Inc: 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, dis

Is my product affected?

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 pati

  • UPC 67016114501
  • UPC 67016114502
  • UPC 67016114503
  • UPC 67016124502
  • UPC 67016124503
  • UPC 67016124504
  • UPC 67017014501
  • UPC 67017024501
  • UPC 67017024502
  • UPC 67017024503
  • UPC 67017024504
  • UPC 67017034501
  • UPC 67017034503
  • UPC 67017044503
  • UPC 67017044504
  • UPC 67017044505
  • UPC 67017054501
  • UPC 67017054502
  • UPC 67017054503
  • UPC 67017054504
  • UPC 67017064501
  • UPC 67017064502
  • UPC 67017064503
  • UPC 67017064504
  • UPC 67017074501
  • UPC 67017074502
  • UPC 67017084501
  • UPC 67017084502
  • UPC 67017104501

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

What happened

Medline Industries Inc is recalling approximately 220,608 units of MEDLINE Sterile Needle Counter, 40 Count Foam Block/Magnet (reorder number DYNJNC40F) due to a packaging seal defect. The product packaging seal may experience "seal creep," which could create gaps in the seals and compromise the sterility of the needle counters. The affected product was distributed nationwide in the United States as well as in Canada, Saudi Arabia, the Cayman Islands, and the United Arab Emirates.

The recalled units are identified by specific lot numbers beginning with "67016114501" through "67017104501." The source record does not specify a remedy or instructions for what consumers should do with recalled product.

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: 220608 units Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

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

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