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U.S. Department of Health and Human Services

Class 2 Device Recall namic Convenience Kits

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  Class 2 Device Recall namic Convenience Kits see related information
Date Initiated by Firm March 12, 2024
Date Posted May 10, 2024
Recall Status1 Open3, Classified
Recall Number Z-1806-2024
Recall Event ID 94313
Product Classification Cardiovascular procedure kit - Product Code OEZ
Product 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
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
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information Contact Karin Johnson
886-359-1704
Manufacturer Reason
for Recall		 Products have a lack of sterility assurance.
FDA Determined
Cause 2		 Process control
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.
Quantity in Commerce 570 units
Distribution US Nationwide distribution in the states of AL, FL, KY, MS, TX, WA, WI, NC, VA, CA, SD, TN, GA, PA, TX.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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