Z-0633-2022 Class II Ongoing
FDA device recall Z-0633-2022 was initiated by MEDLINE INDUSTRIES, LP - Northfield on December 15, 2021 and is designated Class II. Reason for recall: The product contains natural rubber latex but the label states that it does not. The recall status is ongoing. Affected quantity: 494,273 ea.
Recall Details
- Product Type
- Devices
- Report Date
- February 16, 2022
- Initiation Date
- December 15, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 494,273 ea
Product Description
CURAD REUSABLE GEL HOT/COLD PACK
Reason for Recall
The product contains natural rubber latex but the label states that it does not.
Distribution Pattern
US and Bahamas, Bermuda, Panama, Lebanon, Barbados, Honduras, Anguilla
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)