Medline Industries, LP — Class II: MEDLINE Medical Procedure Kits labeled as: 1) CV DRAPING/BASIN, Medline Kit Number/SKU
Medline Industries, LP initiated a Class II recall for several Medical Procedure Kits after an internal review found that catheter components failed to meet performance specifications, including surface finish irregularities, premature connector detachment, and incorrect outer diameters.
This recall affects Medline Industries, LP and healthcare facilities utilizing CV Draping/Basin and Basin Set medical procedure kits with the specific SKUs listed in the notification.
The failure of a catheter to meet physical specifications or maintain structural integrity (connector detachment) during clinical use presents potential safety risks and procedural delays. Since the issues were identified during an internal review, this suggests a possible breakdown in manufacturing quality controls or component supplier oversight. Regulatory teams should note the variety of kits affected, indicating the non-conforming component may be used across multiple product configurations.
QA teams should verify inventory against the specified Kit Number/SKUs and sequester affected lots. Manufacturing and design engineers should investigate the root cause of the connector detachment and surface finish irregularities to determine if these stem from component sourcing or assembly processes. Review incoming inspection protocols for catheters to ensure diameter specifications are consistently met.
Class II. Reason: During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.. Product: MEDLINE Medical Procedure Kits labeled as: 1) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483A; 2) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483B; 3) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483C; 4) CV DRAPING/BASIN 2PART PACK, Medline Kit Number/SKU DYNJ89414; 5) CVG BASIN PACK SC, Medline Kit Number/SKU DYNJ38052G; 6) T/A BASIN SET, Medline Kit Number/SKU DYNJ47941F; 7) VALVE BASIN PACK SC, Medline Kit Number/SKU DYNJ38054G.. Firm: Medline Industries, LP (Northfield IL United States). Status: Ongoing.
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