Medline Industries, LP — Class II: MEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG,
Medline Industries, LP has initiated a Class II recall for various medical procedure kits, including open heart and cardiac packs, due to internal findings that certain catheters failed to meet performance specifications. The identified defects involve surface finish irregularities, premature detachment of catheter connectors from the funnel, and diameter deviations.
This affects Medline Industries, LP, healthcare facilities utilizing cardiac and emergency open-heart procedure kits, and surgical departments (CVOR) responsible for cardiac bypass and related surgeries.
The failure to meet performance specifications for critical surgical components like catheters suggests a breakdown in manufacturing controls or material verification. Because the recall involves cardiac procedure kits, the risks likely relate to procedural delays or potential safety issues if catheters malfunction during surgery. Regulatory professionals should note that this was identified through internal review, emphasizing the importance of ongoing post-market quality assessments.
Quality teams should verify inventory for these specific cardiac procedure kits and await formal recall documentation from the manufacturer. Supply chain and clinical coordinators may need to source alternative packs if the kits are currently used in surgical workflows. QA teams should evaluate if similar catheter assembly issues (surface finish and connector integrity) affect other products within their own portfolios.
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 CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG, APH EMERGENCY OPEN HEART PACK, Etc. (see recall documents for a full list of products). Firm: Medline Industries, LP (Northfield IL United States). Status: Ongoing.
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