3M Steri-Drape Surgical Drape Recall for Adhesive Defect and Skin Injuries
3M is recalling 554,200 surgical drapes due to a difficult-to-remove adhesive liner that may damage the product and render it unusable. The company has received reports of adhesive-related skin injuries from the affected lots.
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 an FDA Class II recall with reported adhesive-related skin injuries, which constitutes significant injury reports meeting the Severe rating criteria.
Plain-English summary
3M is recalling 554,200 units of the 3M Steri-Drape, Medium Drape with Incise Film and Pouch (REF 1061NS), a sterile surgical drape used in general surgery. The product is distributed worldwide.
The recall is due to a defect in the adhesive liner on the drape. The liner is difficult to remove without damaging the product, which may render the drape unusable for its intended surgical purpose. 3M has also observed an increase in reported adhesive-related skin injuries associated with the affected product lots.
Healthcare facilities and individuals should contact 3M regarding the affected lot numbers to arrange product return or replacement.
The recalled product
- Product
- 3M Steri-Drape, Medium Drape with Incise Film and Pouch, REF 1061NS, general surgery drape
- Manufacturer
- 3M Healthcare Business
- Category
- Medical Device — Surgical Drape
- Hazard
- adhesive-defect
- skin-injury
- product-damage
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)
- UDI/DI (01)50707387074079
- Lot numbers: 33HCPF
- 33HD5K
- 33HDAN
- 33HDXM
- 33HEDT
- 33HELW
- 33HEXM
- 33HJRY
- 33HJXT
- 33HK99
- 33HKJJ
- 33HLFP
- 33HLXW
- 33HM9X
- 33HMHE
- 33HMWN
- 33HNLK
- 33HNW9
- 33HP9A
Distribution
Distribution scope not specified by the agency.
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