Recall Z-0259-2023— 3M Healthcare Business
Class II · Ongoing
Class II FDA medical device recall by 3M Healthcare Business, initiated 2022-10-06. FDA's recall record names no specific 510(k) clearance for this event. Product: 3M Steri-Drape, Medium Drape with Wide Adhesive Aperture, REF 1033, general surgery drape. Reason: During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the product unusable. Additionally, 3M has observed an increase in reported adhesive related skin injuries for these affected lots..
- Recalling firm
- 3M Healthcare Business
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-10-06
- Firm location
- Saint Paul, MN, United States
Product description
3M Steri-Drape, Medium Drape with Wide Adhesive Aperture, REF 1033, general surgery drape
Reason for recall
During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the product unusable. Additionally, 3M has observed an increase in reported adhesive related skin injuries for these affected lots.
Data sourced from openFDA. This site is unofficial and independent of the FDA.