Vapor-Clean, Part Number 111AU The Vapor-Clean filter is intended to be used to remove unwanted anesthetic gases from th
FDA device recall Z-1591-2023 · posted 2023-05-16 · Open, Classified
Recall details
- Recalling firm
- Dynasthetics LLC
- Reason for recall
- Due to a manufacturing issue that may result in filter leakage.
- Action taken
- On 5/9/2022, the firm was contacted by their O.U.S. customer regarding the issue with the use of Vapor-Clean filters and failure of pressure test on anesthetic machine. Through the firm's complaint investigation, Dynasthetics LLC was in communication with the customer and instructed the customer to destroy the affected product and to provided proof of destruction. After receiving proof of destruction, Dynasthetics would send replacement filters. For questions regarding this recall, contact Joseph Orr at 801-484-3820 or email jorr@dynasthetics.com.
- Root cause
- Employee error
- Status
- Open, Classified
- Product code
- CBN
- Quantity affected
- 28 filters
- Distribution
- U.S.: N/A O.U.S.: Australia
- Date initiated
- 2022-05-09
- Date posted
- 2023-05-16
- Location
- Salt Lake City, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VAPOR-CLEAR, MODEL 100 (K092031) | Axon Medical, Inc. | 2010-04-16 |