Recalls / —

—#190905

Product

CURAD REUSABLE GEL HOT/COLD PACK

FDA product code

IME — Pack, Hot Or Cold, Reusable

Device class

Class 1

Medical specialty

Physical Medicine

Affected lot / code info

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)

Why it was recalled

The product contains natural rubber latex but the label states that it does not.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

The 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.

Recalling firm

Firm

MEDLINE INDUSTRIES, LP Northfield

Address

3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern

US and Bahamas, Bermuda, Panama, Lebanon, Barbados, Honduras, Anguilla

Timeline

Recall initiated

2021-12-15

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #190905. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.