Recall Z-0633-2022 ยท IME Pack, Hot Or Cold, Reusable
MEDLINE INDUSTRIES, LP - Northfield
CURAD REUSABLE GEL HOT/COLD PACK
| Date | Dec 15, 2021 |
| Status | Open, Classified |
| Reason | The product contains natural rubber latex but the label states that it does not. |
| 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 | 494,273 ea |
| Distribution | US and Bahamas, Bermuda, Panama, Lebanon, Barbados, Honduras, Anguilla |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.