3M Steri-Drape Surgical Drape Recalled for Adhesive Skin Injuries
3M Healthcare is recalling Steri-Drape surgical drapes due to an adhesive component that causes skin injuries and may render the product unusable. Affected: 104,000 units worldwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is a Class II FDA-regulated medical device recall with reported adhesive-related skin injuries among users. The documented injury reports meet the rubric criterion for Severe classification.
Plain-English summary
3M Healthcare is recalling 104,000 units of Steri-Drape Small Drape with Incise Film (REF 1021NS) due to problems with the adhesive component liner.
During investigation, 3M confirmed that the liner on the adhesive component is difficult to remove without damaging the product, which may render it unusable. Additionally, 3M has observed an increase in reported adhesive-related skin injuries associated with the affected drapes.
The affected drapes have been distributed worldwide. The recall includes 9 lot numbers: 33HT9W, 33HWN8, 33J5T9, 33JL66, 33JLLW, 33JMKR, 33JN4N, 33K7Y7, and 33K888.
Healthcare facilities and users should identify and quarantine affected drapes and contact 3M for further instructions.
The recalled product
- Product
- 3M Steri-Drape, Small Drape with Incise Film, REF 1021NS, general surgery drape
- Manufacturer
- 3M Healthcare Business
- Category
- Medical Device — Surgical Drape
- Hazard
- adhesive-skin-injury
- product-defect
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 (10)
- UDI/DI (01)50707387497410
- Lot numbers: 33HT9W
- 33HWN8
- 33J5T9
- 33JL66
- 33JLLW
- 33JMKR
- 33JN4N
- 33K7Y7
- 33K888
Distribution
Distribution scope not specified by the agency.
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