Medline TheraHoney Gel Wound Dressing Recalled for Sterilization Failure
Medline is recalling 851,328 units of TheraHoney Gel wound dressing due to inadequate sterilization. The manufacturer failed to augment the sterilization dose after an audit failure, violating ISO 11137 standards.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device with no reported illnesses or injuries. This recall qualifies as a risk-of-harm product where injury has not yet been reported, per the rubric criterion for High severity.
Plain-English summary
Medline Industries, LP is recalling TheraHoney Gel wound dressing, composed of 100% Leptospermum scoparium honey. The recall affects 851,328 units distributed worldwide to the United States and to Singapore, Dominican Republic, United Arab Emirates, Dubai, China, Panama, Canada, Saudi Arabia, Bermuda, Colombia, Mauritius, and Kuwait.
Two product SKUs are being recalled: REF MNK0005 and REF MNK0015, with specific lot numbers identified for each SKU. The manufacturer notified Medline of a sterilization dose audit failure on the wound gel. Following the audit failure, the sterilization dose was not augmented as required by ISO 11137 sterilization standards.
Inadequate sterilization of a medical device used on wounds presents a potential risk of microbial contamination.
The recalled product
- Product
- MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Wound Dressing
- Affected units
- 851,328
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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