Medline Needle Counters Recalled Due to Packaging Seal Creep
Medline Industries Inc is recalling MEDLINE O.R. Necessities Sterile Needle Counters because packaging seal creep may compromise sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The FDA classification is Class II, which typically indicates a moderate risk. However, the hazard involves compromised sterility of a medical device used in surgical settings, which poses a significant risk of infection if used. This aligns with the 'risk-of-harm products where injury has not yet been reported' criterion for a High severity score.
Plain-English summary
Medline Industries Inc has initiated a recall of the MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 100 Ct. Double Magnet / Foam Block with Blade Remover (reorder: NC100FBR). The product is designed to safely account for used, disposable surgical sharps during procedures and does not come into contact with the surgical site or the patient.
The recall addresses a potential defect in the product packaging seal known as "seal creep." This issue may create gaps in the seals, which could impact the sterility of the needle counters. The affected units are distributed nationwide in the US and in Canada, Saudi Arabia, the Cayman Islands, and the United Arab Emirates.
The recall involves 80,200 units associated with specific lot numbers including 67016114502, 67016124501, 67016124502, 67016124507, 67017014501, 67017024502, 67017034501, 67017034503, 67017064502, 67017074502, 67017084502, 67017084503, 67017094501, 67017094503, 67017094505, 67017104501, 67017114501, and 67017114502. The U.S. Food and Drug Administration has classified this recall as Class II.
The recalled product
- Product
- 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.
- Manufacturer
- Medline Industries Inc
- Affected units
- 80,200
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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