Medline Therahoney GEL recall
MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel
Why was Medline Therahoney GEL recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- 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.
- Recall date
- June 28, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)