BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.
FDA device recall Z-1189-2023 · posted 2023-03-13 · Terminated
Recall details
- Recalling firm
- Avanos Medical, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- BSY
- Quantity affected
- 780 units
- Distribution
- US Nationwide distribution in the state of Oklahoma.
- Date initiated
- 2023-02-03
- Date posted
- 2023-03-13
- Date terminated
- 2024-09-05
- Location
- Alpharetta, GA
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