Medline Sterile Needle Counter Recall Due to Packaging Seal Creep
Medline Industries is recalling sterile needle counters because packaging seal creep may compromise sterility.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Medline Industries Inc is recalling 23,150 units of MEDLINE O.R. Necessities Sterile Needle Counters (reorder code NC100FBR). The recall involves specific lot numbers: 67016114502, 67017014501, 67017024502, and 67017054501. The product is intended to account for used, disposable surgical sharps during procedures and does not come in contact with the surgical site or the patient.
The recall was initiated because the product packaging seal has the potential to experience seal creep. This condition may result in gaps in the packaging seals, which may impact the sterility of the needle counters.
The affected products were distributed worldwide, including the United States, Canada, Saudi Arabia, the Cayman Islands, and the United Arab Emirates. The FDA has classified this as a Class II recall. Healthcare facilities and consumers should stop using the affected units and contact Medline Industries for further instructions.
The recalled product
- Product
- MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 40 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.
- Manufacturer
- Medline Industries Inc
- Affected units
- 23,150
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: 67016114502 67017014501 67017024502 67017054501
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Medline Industries Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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