Medline Industries, LP — Class II: Medline surgical convenience kits labeled as: 1) OPEN HEART PACK A & B, Medline Produc
Medline Industries, LP has initiated a Class II recall for 29 types of surgical convenience kits, including open heart, vascular, and transplant packs, due to non-conforming cannula components. These components do not meet ISO 80369-7 dimensional requirements, posing a risk of leaking or breaking during surgical use.
This recall affects Medline Industries, LP, healthcare providers utilizing specialized surgical kits (specifically for cardiovascular, transplant, and vascular procedures), and supply chain professionals responsible for surgical inventory management.
The failure to meet ISO 80369-7 standards for small-bore connectors in surgical kits suggests a vulnerability in the qualification process for third-party components within convenience kits. Regulatory teams should consider the implications of component-level non-conformance on the safety profile of the final finished kit, particularly in high-stakes environments like cardiac and transplant surgery where device failure can lead to significant clinical complications.
Inventory teams should immediately identify and quarantine the specific SKUs listed in the recall. Regulatory and QA departments should review the compliance of all kit components against ISO 80369-7 standards, specifically focusing on luer connector dimensions, to prevent potential leakage or mechanical failure during critical procedures.
Class II. Reason: Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.. Product: Medline surgical convenience kits labeled as: 1) OPEN HEART PACK A & B, Medline Product number/SKU DYNJ04584L; 2) OPEN HEART ACCESSORY PACK, Medline Product number/SKU DYNJT5715A; 3) CABG ACCESSORY PACK, Medline Product number/SKU DYNJ85751; 4) OPEN HEART PACK, Medline Product number/SKU DYNJ53741N; 5) OPEN HEART PACK 1&2, Medline Product number/SKU DYNJ80701A; 6) VEIN PACK, Medline Product number/SKU DYNJ67308C; 7) OPEN HEART PACK, Medline Product number/SKU DYNJ89451B; 8) VASCULAR TRAY-LF, Medline Product number/SKU DYNJ42166A; 9) ENDOSCOPIC VEIN HARVEST PK, Medline Product number/SKU DYNJ67363C; 10) ENDOSCOPIC VEIN HARVEST PK, Medline Product number/SKU DYNJ67363B; 11) LIVER TRANSPLANT PACK B, Medline Product number/SKU DYNJ65779B; 12) CABG PACK-LF, Medline Product number/SKU DYNJ47661J; 13) VEIN HARVEST PACK, Medline Product number/SKU DYNJ04470L; 14) CARDIAC PACK, Medline Product number/SKU DYNJ44647D; 15) GM OPEN HEART ACC PACK-LF, Medline Product number/SKU DYNJ0660029AM; 16) CARDIOVASCULAR PACK-LF, Medline Product number/SKU DYNJ0160327C; 17) GOOD SHEPHERD OPEN HEART, Medline Product number/SKU DYNJ60819L; 18) OPEN HEART PACK, Medline Product number/SKU DYNJ0271227R; 19) OPEN HEART PACK, Medline Product number/SKU DYNJ81541C; 20) TAVR PACK, Medline Product number/SKU DYNJ54094F; 21) TRANSPLANT BACKTABLE PACK, Medline Product number/SKU DYNJ62055C; 22) VASCULAR, Medline Product number/SKU DYNJ49366; 23) BACK TABLE TRAY, Medline Product number/SKU DYNJ65416D; 24) CV PART 1 AND 2, Medline Product number/SKU DYNJ908879G; 25) OPEN HEART A B PACK, Medline Product number/SKU DYNJ81096B; 26) KIDNEY, Medline Product number/SKU DYNJ54732I; 27) ABDOMINAL PRESEVERVATION PACK, Medline Product number/SKU DYNJ62691F; 28) LIVER PACK SAFETY, Medline Product number/SKU DYNJ54734I; 29) CV PROCEDURE PART A, Medline Product number/SKU DYNJ903745I;. Firm: Medline Industries, LP (Northfield IL United States). Status: Ongoing.
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