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Recall Observatory FDA recall evidence

Device product

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

Z-1189-2023

February 03, 2023

Class I

Product summary

Firm
Avanos Medical, Inc.
Event
Event 91663
Status
Terminated
Classification
Class I
Quantity
780 units
Official record key
device-enforcement:Z-1189-2023

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): B30511 (20098360), B30611 (20098361), B30711 (20097200), B30811 (20098362), B31011 (20098363).

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.