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U.S. Department of Health and Human Services

Class 2 Device Recall CURAD

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 Class 2 Device Recall CURADsee related information
Date Initiated by FirmDecember 15, 2021
Create DateFebruary 09, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0633-2022
Recall Event ID 89235
Product Classification Pack, hot or cold, reusable - Product Code IME
ProductCURAD REUSABLE GEL HOT/COLD PACK
Code Information Item Numbers: 1) CUR959/CUR959H (Lots 69718070004, 69718090003, 69718100001, 69718100004, 69718110003, 69719010001, 69719030001, 69719030004, 69719040002, 69719070005, 69719080002, 69719080006, 69719090001, 69719090004, 69719100001, 69719100004, 69719110001, 69719110003, 69719110004, 69719120001, 69719120005, 69719120002, 69719120006, 69720010001, 69720020002, 69720040001, 69720050001, 69720060001, 69720060002, 69720080002, 69720090001, 69720090002, 69720100001, 69720100002, 69720110002, 69720120001, 69720120002, 69721010001, 69721020001, 69721030001, 69721030002, 69721050001, 69721050002, 69721050003, 69721060001, 69721060002, 69721070001, 69721080002, 69721090001) 2) TGT0114V1 (Lots 69718070004, 69718080002, 69718090002 , 69718100004, 69718110003, 69719010001, 69719030004, 69719040002, 69719050002, 69719050004, 69719060001, 69719060003, 69719070001, 69719070005, 69719080002, 69719080006, 69719090004, 69719100001, 69719100004, 69719100005, 69719110001, 69719110002, 69719110004, 69719110003, 69719120005, 69719120002, 69719120007, 69719120006, 69720010001, 69720070001, 69720070002, 69720080001, 69720080002, 69720100003)
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactMs. Karin Johnson
866-359-1704
Manufacturer Reason
for Recall		The product contains natural rubber latex but the label states that it does not.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe firm initiated the recall by letter on 12 December 2021. The letter explained the issue and requested destruction of the product. Any entity transferring the product was required to notify their customers.
Quantity in Commerce494,273 ea
DistributionUS and Bahamas, Bermuda, Panama, Lebanon, Barbados, Honduras, Anguilla
Total Product Life CycleTPLC 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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