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Recall Observatory FDA recall evidence

Device product

MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel

Z-1982-2023

May 03, 2023

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 92327
Status
Ongoing
Classification
Class II
Quantity
851,328 units
Official record key
device-enforcement:Z-1982-2023

Official wording

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.

Code information: 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

Distribution pattern: Worldwide distribution - US Nationwide and the countries of SINGAPORE, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES, DUBAI, CHINA, PANAMA, CANADA, SAUDI ARABIA, BERMUDA, COLOMBIA, MAURITIUS, KUWAIT.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.