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

Medline Industries Inc: 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, C

Is my product affected?

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 - O

  • UPC 67016114502
  • UPC 67016124502
  • UPC 67017014501
  • UPC 67017024502
  • UPC 67017064502
  • UPC 67017064503
  • UPC 67017074501
  • UPC 67017074502
  • UPC 67017084502
  • UPC 67017084503
  • UPC 67017104501

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 Counters in 40-count foam block packages with either a gold standard or standard blade remover and magnet. The packaging seals on these products have the potential to experience seal creep, which can create gaps in the seals and compromise the sterility of the needle counters. The recall affects approximately 2,600 units distributed worldwide, including throughout the United States and in Canada, Saudi Arabia, the Cayman Islands, and the United Arab Emirates.

The affected products are identified by the following lot numbers: 67016114502, 67016124502, 67017014501, 67017024502, 67017064502, 67017064503, 67017074501, 67017074502, 67017084502, and 67017084503. The recall notice does not specify what actions consumers should take regarding their affected 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: 2600 units Lot/code info: Lot Numbers: 67016114502 67016124502 67017014501 67017024502 67017064502 67017064503 67017074501 67017074502 67017084502 67017084503 67017104501

Source

Official record: FDA (Device enforcement) ↗

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

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