Z-1806-2024 Class II Ongoing
FDA device recall Z-1806-2024 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Mar 12, 2024 and is designated Class II. Reason for recall: Products have a lack of sterility assurance. The recall status is ongoing. Affected quantity: 570 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2024
- Initiation Date
- Mar 12, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 570 units
Product Description
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
Reason for Recall
Products have a lack of sterility assurance.
Distribution Pattern
US Nationwide distribution in the states of AL, FL, KY, MS, TX, WA, WI, NC, VA, CA, SD, TN, GA, PA, TX.
Code Information
a) UDI/DI 10193489040456, Lot Numbers: 0000113192; b) UDI/DI 10193489044195, Lot Numbers: 0000113331; c) UDI/DI 10193489044386, Lot Numbers: 0000112999; d) UDI/DI 10193489044416, Lot Numbers: 0000113000; d) UDI/DI 10193489044935, Lot Numbers: 0000113187; e) UDI/DI f) UDI/DI g) UDI/DI h) UDI/DI i) UDI/DI j) UDI/DI k) UDI/DI l) UDI/DI m) UDI/DI n) UDI/DI o) UDI/DI p) UDI/DI q) UDI/DI
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1806-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026