OECDReference EN/CR/RV-01-2023
3M™ Steri-Drape™ Surgical Drapes
Official information organised for easier consultation. The source publication remains authoritative.
Identification
Product identification
- Product
- 3M™ Steri-Drape™ Surgical Drapes
- Category
- Surgery Materials
- Model
- Catalog Numbers 1000, 1000NS,1000NSD, 1010, 1010NS, 1010NSD, 1020, 1020NS, 1021, 1021NS, 1030, 1030NS,1033, 1060, 1060NS, 1061, 1061NS, 1071
Official information
Risk and measures
- Risk or hazard
- 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. Although the acceptance criteria for the device was met upon product release, the adhesive component may not meet 3M’s performance criteria throughout product shelf life. 3M requests customers cease use of the product and quarantine it for destruction/disposal.
- Recommendations
- Immediately cease use of affected models and lots of 3M™ Steri-Drape™ Surgical Drapes.
Official information
Economic operators
- Manufacturer
- 3M Health Care
Territory
Geography
- Distribution
- Retirada en Costa Rica
- Country of recall
- Costa Rica
Provenance and context
NagameAlert distinguishes content published by the source from its organisation and normalisation. Values marked “NagameAlert” belong to that processing layer. Always check measures, scope and updates in the official publication.