In-Line ventilator adaptor
FDA device recall Z-1139-2022 · posted 2022-05-30 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corporation
- Reason for recall
- There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment.
- Action taken
- The recall notification was sent to consignees on 04/26/2022 via FedEx. The customer was instructed to sign acknowledgement form to confirm receipt and return to Hillrom using pre-paid envelope.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- NHJ
- Quantity affected
- 9 units
- Distribution
- US Nationwide distribution in the states of TX, FL, VA, KY, CA, AZ, WI, IL, NC, OH, MI, MS, MO, MN, AL, TN, SD, OK, NV, NJ, IN, CO, GA, WA, PA, IA, NE, NM, SC, ND, KS, WV, OR.
- Date initiated
- 2022-04-26
- Date posted
- 2022-05-30
- Date terminated
- 2024-08-20
- Location
- Deerfield, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Maximus System (K200988) | Hill-Rom Services Pte, Ltd. | 2020-05-26 |