Known Identifiers & Locations
FEI Numbers
2110898
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (0)
No 510(k) notifications found for this entity.
FDA Recall History (2)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0022-2013 |
3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL.
3M Steri-Vac Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for indoor use only.
Reason: 3M determined that the electrical grounding mechanism for the Steri-Vac 5XL and 8XL gas Sterilizer/Aerator did not meet all of the requirements of the standard in that the electrical wiring, which is insulated and contained within the sealed door should have a stronger connection to the protective electrical grounding mechansim.
|
2012-09-13 |
Terminated
|
View Details
|
| Z-0038-2025 |
3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Reason: Contamination with foreign substance matter
|
2024-08-14 |
Open, Classified
|
View Details
|
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