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WarningRecall #Z-1886-2026Medical Device

Medline Industries Recalls Medline Convenience Kits containing select SKUs of 10mL.

Medline Industries, LP · Class II — Moderate Risk

Hospital operating room medical equipment — representative photo for FDA medical device recall
A hospital operating room with medical equipment (representative file photo). Specific recalled device: see recall details below. Photo: FDA / Public Domain.

Product Description

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EYE PACK DYNJ35056A HEART CATH PACK DYNJ69318A

Reason for Recall

Unapproved design changes to the products outside of the 510(k) clearance.

FDA Classification

Class II — Moderate Risk

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.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.

Remedy

Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.

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