Recall Z-1190-2023 ยท BSY Catheters, Suction, Tracheobronchial
Avanos Medical, Inc.
BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold.
| Date | Mar 13, 2023 (initiated Feb 3, 2023) |
| Status | Terminated |
| Reason | Potential for product manifold to crack during use on patients, possibly causing leaks in the respiratory circuit and can lead to the patient receiving inadequate ventilation. |
| Root cause | Component design/selection |
| Action | Avanos hand-delivered the recall notification to the single consignee on 02/03/2023. The letter instructed the customer to discontinue use of and quarantine their stock of all lots of affected units and return them. Additionally, the customer was instructed to complete and return the acknowledgement form. |
| Quantity | 220 units |
| Distribution | US Nationwide distribution in the state of Oklahoma. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.