MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel
Reported: June 28, 2023 Initiated: May 3, 2023 #Z-1982-2023
Product Description
MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel
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.
Details
- Recalling Firm
- MEDLINE INDUSTRIES, LP - Northfield
- Units Affected
- 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.
- Location
- Northfield, IL
Frequently Asked Questions
What product was recalled? ▼
MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 851,328 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 28, 2023. Severity: Moderate. Recall number: Z-1982-2023.
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