3M Steri-Drape, Medium Drape with Incise Film, REF 1060NS, general surgery drape
Reported: November 30, 2022 Initiated: October 6, 2022 #Z-0261-2023
Product Description
3M Steri-Drape, Medium Drape with Incise Film, REF 1060NS, 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.
Details
- Recalling Firm
- 3M Healthcare Business
- Units Affected
- 103,000 units
- Distribution
- Worldwide distribution.
- Location
- Saint Paul, MN
Frequently Asked Questions
What product was recalled? ▼
3M Steri-Drape, Medium Drape with Incise Film, REF 1060NS, general surgery drape. Recalled by 3M Healthcare Business. Units affected: 103,000 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 30, 2022. Severity: Moderate. Recall number: Z-0261-2023.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11