CURAD REUSABLE GEL HOT/COLD PACK
FDA Recall #Z-0633-2022 — Class II — December 15, 2021
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.
Recalling Firm
MEDLINE INDUSTRIES, LP - Northfield — Northfield, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
494,273 ea
Distribution
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)
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.