3M Healthcare Business
Saint Paul, MN, US
3M Healthcare Business appears in FDA device records in Saint Paul, MN. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 18 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 18
- Registered establishments
- 0
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0264-2023 | 3M Steri-Drape, Urological Drape, REF 1071, general surgery (urology) drape | 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. | Class II | Open, Classified | |
| Z-0263-2023 | 3M Steri-Drape, Medium Drape with Incise Film and Pouch, REF 1061NS, general surgery drape | 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. | Class II | Open, Classified | |
| Z-0262-2023 | 3M Steri-Drape, Medium Drape with Incise Film and Pouch, REF 1061, general surgery drape | 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. | Class II | Open, Classified | |
| Z-0261-2023 | 3M Steri-Drape, Medium Drape with Incise Film, REF 1060NS, general surgery drape | 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. | Class II | Open, Classified | |
| Z-0260-2023 | 3M Steri-Drape, Medium Drape with Incise Film, REF 1060, general surgery drape | 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. | Class II | Open, Classified | |
| Z-0259-2023 | 3M Steri-Drape, Medium Drape with Wide Adhesive Aperture, REF 1033, general surgery drape | 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. | Class II | Open, Classified | |
| Z-0258-2023 | 3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030NS, general surgery drape | 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. | Class II | Open, Classified | |
| Z-0257-2023 | 3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030, general surgery drape | 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. | Class II | Open, Classified | |
| Z-0256-2023 | 3M Steri-Drape, Small Drape with Incise Film, REF 1021NS, general surgery drape | 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. | Class II | Open, Classified | |
| Z-0255-2023 | 3M Steri-Drape, Small Drape with Incise Film, REF 1021, general surgery drape | 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. | Class II | Open, Classified | |
| Z-0254-2023 | 3M Steri-Drape, Small Drape with Adhesive Aperture, REF 1020NS, general surgery drape | 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. | Class II | Open, Classified | |
| Z-0253-2023 | 3M Steri-Drape, Small Drape with Adhesive Aperture, REF 1020, general surgery drape | 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. | Class II | Open, Classified | |
| Z-0252-2023 | 3M Steri-Drape, Large Towel Drape, REF 1010NSD, general surgery drape | 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. | Class II | Open, Classified | |
| Z-0251-2023 | 3M Steri-Drape, Large Towel Drape, REF 1010NS, general surgery drape | 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. | Class II | Open, Classified | |
| Z-0250-2023 | 3M Steri-Drape, Large Towel Drape, REF 1010, general surgery drape | 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. | Class II | Open, Classified | |
| Z-0249-2023 | 3M Steri-Drape, Small Towel Drape, REF 1000NSD, general surgery drape | 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. | Class II | Open, Classified | |
| Z-0248-2023 | 3M Steri-Drape, Small Towel Drape, REF 1000NS, general surgery drape | 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. | Class II | Open, Classified | |
| Z-0247-2023 | 3M Steri-Drape, Small Towel Drape, REF 1000, general surgery drape | 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. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain