Z-0633-2022Class II

Curad Reusable Gel Hot/cold Pack

Name: Z-0633-2022 Curad Reusable Gel Hot/cold Pack
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2021-12-15
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2021-12-15 / Open, Classified / root cause: manufacturing process

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of CURAD REUSABLE GEL HOT/COLD PACK on 2021-12-15. FDA classified it as Class II and gives the reason as "The product contains natural rubber latex but the label states that it does not". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0633-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-12-15
Posted: 2022-02-09
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Curad Reusable Gel Hot/cold Pack
Product code: IME Pack, Hot Or Cold, Reusable
Reason for recall: The product contains natural rubber latex but the label states that it does not.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 494,273 ea
Distribution: US and Bahamas, Bermuda, Panama, Lebanon, Barbados, Honduras, Anguilla
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0633-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0633-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-16	2022-02-09

Product code IME

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)