Medline Industries, LP — Class II: MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Kit/SKU DYNJ673
Medline Industries, LP has initiated a Class II recall for multiple medical procedure kits, including cardiac surgery and ECMO packs, due to catheter components failing to meet performance specifications. Specific issues identified include surface finish irregularities, premature connector detachment from the catheter funnel, and outer diameter measurements that did not meet specifications.
This recall affects Medline Industries, LP, healthcare facilities utilizing these specific surgical and cardiovascular procedure kits (SKUs DYNJ67331B, DYNJ911589A, DYNJ36211D, among others), and clinical staff involved in cardiac, carotid, and ECMO procedures.
This event suggests a failure in component-level quality control or supplier management within the kit assembly process. For regulatory professionals, it highlights the risks associated with convenience kits where a single defective component can compromise the compliance status of an entire multi-product surgical pack. The detachment of connectors and diameter deviations may present clinical challenges during high-risk cardiovascular interventions.
Inventory managers should immediately isolate affected SKU lots listed in the recall. Quality teams should review internal inspection protocols for catheter components within convenience kits to ensure surface finish and connector integrity meet established performance specifications. Regulatory units should document the impact on surgical kit availability for cardiovascular procedures.
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) BASIC HEART PACK, Medline Kit/SKU DYNJ67331B; 2) CARDIAC SURGERY, Medline Kit/SKU DYNJ911589A; 3) CAROTID ENDARTECOMY, Medline Kit/SKU DYNJ36211D; 4) CHLA ECMO / CARDIAC PACK, Medline Kit/SKU DYNJ87973; 5) CHLA ECMO / CARDIAC PACK, Medline Kit/SKU DYNJ87973A; 6) CV PART 1 AND 2, Medline Kit/SKU DYNJ908879; 7) CV PART 1 AND 2, Medline Kit/SKU DYNJ908879C; 8) FEM POP CDS, Medline Kit/SKU CDS983670K; 9) LAP BASIN TRAY, Medline Kit/SKU DYNJ50908B; 10) OPEN HEART LTX CATHETERS KIT, Medline Kit/SKU DYNJ0049032A; 11) OPEN HEART PACK, Medline Kit/SKU DYNJ80549C; 12) OPEN HEART PACK, Medline Kit/SKU DYNJ80549D; 13) RR-ADULT ECMO PACK, Medline Kit/SKU DYNJ69742B; 14) TAVR, Medline Kit/SKU DYNJ906509C.. Firm: Medline Industries, LP (Northfield IL United States). Status: Ongoing.
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