Medline Sterile Needle Counter Recall Due to Packaging Seal Creep
Medline is recalling Sterile Needle Counters because packaging seal creep may compromise sterility. The recall covers 38,464 units distributed in the US, Canada, and other countries.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 recall is classified as FDA Class II. The hazard involves potential loss of sterility in a medical device used in surgical settings, which presents a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Medline Industries Inc is recalling 38,464 units of MEDLINE Sterile Needle Counters (reorder code DYNJNC40A). The recall is due to a potential issue with the product packaging seal, which may experience 'seal creep.' This defect can create gaps in the packaging seals, potentially impacting 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 recall includes specific lot numbers ranging from 67016114501 to 67017104502. The needle counters are intended to be used to account for used, disposable surgical sharps during surgical procedures and do not come in contact with the surgical site or the patient.
Healthcare facilities and consumers should check their inventory for the affected lot numbers. If the product is found, it should be removed from use and returned to Medline Industries Inc according to the recall instructions.
The recalled product
- Product
- MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Adhesive, reorder: DYNJNC40A 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…
- Manufacturer
- Medline Industries Inc
- Affected units
- 38,464
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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Similar recalls
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