MEDLINE INDUSTRIES, LP - Northfield: MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel

Hazard

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.

Details from the source

Reason for recall: 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. 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 Lot/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

UPC codes

30884389161566, 40884389154558

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.