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Terminated

BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.

FDA Recall Z-1189-2023 · Posted 2023-03-13

Recalling FirmAvanos Medical, Inc.
Recall StatusTerminated
Product CodeBSY
Date Initiated2023-02-03
Date Terminated2024-09-05
Product Quantity780 units

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.

Firm 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.

Root Cause

Component design/selection

Distribution Pattern

US Nationwide distribution in the state of Oklahoma.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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