MEDLINE INDUSTRIES, LP – Northfield Recall 92327
Description: MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel
MEDLINE INDUSTRIES, LP – Northfield Recall 92327 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1982-2023 |
| Event ID | 92327 |
| Event Description | MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel |
| Product Type | Devices |
| 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. |
| Quantity | 851,328 units |
| Recall 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. |
| Device Classification | 20230628 |
| Device Code Info | a) REF MNK0005: GTIN 30884389161566, Lot Numbers: LMPTH0189, LMPTH0191, LMPTH0193, LMPTH0195, LMPTH0197, LMPTH0199, LMPTH0201, LMPTH0203, LMPTH0205, LMPTH0207, LMPTH0211, LMPTH0213; b) REF MNK0015: GTIN 40884389154558, Lot Numbers: LMPTH0188, LMPTH0190, LMPTH0192, LMPTH0196, LMPTH0198, LMPTH0200, LMPTH0202, LMPTH0204, LMPTH0206, LMPTH0210, LMPTH0210B, LMPTH0212 |
| Center Classification Date | 20230621 |
| Recall Initiation Date | 20230503 |
| Recalling Firm | MEDLINE INDUSTRIES, LP - Northfield |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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