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Recall Observatory FDA recall evidence

Device product

BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold.

Z-1190-2023

February 03, 2023

Class I

Product summary

Firm
Avanos Medical, Inc.
Event
Event 91663
Status
Terminated
Classification
Class I
Quantity
220 units
Official record key
device-enforcement:Z-1190-2023

Official wording

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.

Code information: All lots are affected. Stock Code (Lot Number): B50511 (20098277), B50611 (20098278), B50711 (20098279), B50811 (20097177, 20097177R1).

Distribution pattern: US Nationwide distribution in the state of Oklahoma.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.