Recall Z-1982-2023 ยท FRO Dressing, Wound, Drug
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel
| Date | Jun 21, 2023 (initiated May 3, 2023) |
| Status | Open, Classified |
| Reason | Medline issued a recall on TheraHoney Wound Gel due to the manufacturer notifying Medline of a sterilization dose audit failure on the wound gel and not augmenting the dose after failure per ISO 11137. |
| Root cause | Under Investigation by firm |
| Action | Medline issued a recall notice to its consignees on 05/03/2023 by first calls mail and email The notice explained the problem with the device, risk and requested the following: "REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers listed on the recall portal. Destroy affected product.2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. The |
| Quantity | 851,328 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of SINGAPORE, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES, DUBAI, CHINA, PANAMA, CANADA, SAUDI ARABIA, BERMUDA, COLOMBIA, MAURITIUS, KUWAIT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131796 | MANUKA FILL WOUND DRESSING Links Medical Products, Inc., Mar 14, 2014 |