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Open, Classified

namic CONVENIENCE KIT, a) CAROTID MANIFOLD KIT, REF 60011045; b) 3V MANIFOLD KIT ON WITH NAMIC DT & WASTE MANAGEMENT, REF 60070582; c) LEFT HEART KIT, REF 60071822; d) LEFT HEART KIT, REF 60080085; e) CONVENIENCE KIT, REF 60100055; f) CONVENIENCE KIT, REF 60101041; g) CONVENIENCE KIT, REF 60120336; h) LEFT HEART KIT, REF 60131446; i) 3 VALVE MANIFOLD OFF KIT WITH SQUEEZE CONTRAST CONTROLLER AND PROTECTION STATION, REF 60140798; j) CONVENIENCE KIT, REF 60142592; k) LEFT HEART KIT, REF 60183972; l) FOUR VALVE MANIFOLD KIT, REF 60210209; m) RIGHT HEART KIT, REF 60210862; n) LEFT HEART KIT, REF 600705710; o) CONVENIENCE KIT, REF 600803410; p) TUBING KIT; REF 601322913; q) LEFT HEART KIT, REF 60032582A

FDA Recall Z-1806-2024 · Posted 2024-05-10

Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
Recall StatusOpen, Classified
Product CodeOEZ
Date Initiated2024-03-12
Product Quantity570 units

Reason for Recall

Products have a lack of sterility assurance.

Firm Action

Medline issued a Medical Device Recall notice to its consignees on 03/12/2024 via email and US Mail. The notice explained the issue, potential risk, and requested destruction of the affected product. Those who further distributed the product were directed to notify those to whom they shipped the product.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution in the states of AL, FL, KY, MS, TX, WA, WI, NC, VA, CA, SD, TN, GA, PA, TX.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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