3M Steri-Drape Medium Drape Recalled for Adhesive Skin Injuries
3M is recalling approximately 14,360 units of Steri-Drape surgical drapes due to adhesive-related skin injuries. The product's adhesive liner is difficult to remove and may render the drape unusable.
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: FDA Class II device with reported adhesive-related skin injuries affecting over 14,000 units in worldwide distribution. Reported skin injuries on medical devices used in surgical settings constitute significant harm meeting the criteria for Severe classification.
Plain-English summary
3M Healthcare Business is recalling the 3M Steri-Drape, Medium Drape with Wide Adhesive Aperture (REF 1033), a general surgery drape. The adhesive liner on the product is difficult to remove without damaging the product and may render it unusable. 3M has observed an increase in reported adhesive-related skin injuries for the affected lots.
This recall affects approximately 14,360 units distributed worldwide. The affected lot numbers are: 33H9JH, 33J6KY, 33JCP7, 33JRD4, 33JYJ5, 33K6E3, 33KFAC, 33KHKL, 33L6E6, and 33LAXJ. The product's UDI/DI code is (01)3070387454587.
Healthcare providers should identify any affected products in their facilities using the lot numbers provided. Products matching the recalled lots should not be used. Contact 3M directly with questions regarding the recall or if skin injuries have been experienced.
The recalled product
- Product
- 3M Steri-Drape, Medium Drape with Wide Adhesive Aperture, REF 1033, 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 (11)
- UDI/DI (01)3070387454587
- Lot numbers: 33H9JH
- 33J6KY
- 33JCP7
- 33JRD4
- 33JYJ5
- 33K6E3
- 33KFAC
- 33KHKL
- 33L6E6
- 33LAXJ
Distribution
Distribution scope not specified by the agency.
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