Medline Industries, LP — Class II: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CATARAC
Medline Industries, LP has initiated a Class II recall for select convenience kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes that fall outside the scope of the FDA-cleared 510(k).
Medline Industries, LP, healthcare facilities utilizing specialized surgical packs (e.g., Cataract, Vascular, Pediatric, Spine, and Angiogram packs), and regulatory compliance professionals managing convenience kit labeling and 510(k) adherence.
This action underscores the regulatory risk associated with modifying individual components within pre-assembled convenience kits without updated clearance. It suggests that the FDA is monitoring whether design iterations on sub-components necessitate new 510(k) submissions to maintain compliance. Operating outside of cleared design specifications may lead to enforcement actions even if the device's primary function remains unchanged.
Regulatory teams should verify that all components within convenience kits align with the specific design specifications of their respective 510(k) clearances. QA departments should review change control documentation to ensure that design modifications have been assessed for New 510(k) requirements before market distribution.
Class II. Reason: Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.. Product: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CATARACT FULL BODY DYNJ85743 MAJOR VASCULAR PACK DYNJ81610C MINIMALLY INVASIVE PACK-LF DYNJ0843063L PEDIATRIC CATH ANGIO PACK DYNJ54755J PERIPHERAL ARTERIOGRAM RAD DYNJ61383C POSTERIOR SPINE PACK-LF DYNJ0843339O UPPER EXTREMITY DYNJ61907A VISCERAL ANGIOGRAM PACK-LF DYNJ0429121L. Firm: Medline Industries, LP (Northfield IL United States). Status: Ongoing.
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