Medical Device Recall: Z-0038-2010

FDA Recalls dataset · Firm: Airgas Puritan Medical Puritan Medical Unit · Status: Terminated

Recall Action Class: N/A Date Initiated: 2009-08-06 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0038-2010.

Recall Res Number
Z-0038-2010
Recalling Firm / Manufacturer
Airgas Puritan Medical Puritan Medical Unit
FEI Number
N/A
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2009-08-06
Date Posted
2009-10-14
Date Terminated
2010-01-26
Product Code
CAN
Event Number
53081
Product Quantity
208
Product Description AGI-2238 Portable 4 Cylinder Manifold Cart, for connecting medical gas cylinders.
Reason for Recall Yoke may become displaced. Yoke index safety system could become compromised, allowing a user to attach the wrong gas type to the yoke connection.
Action Details Airgas issued a Medical Device Removal letter dated 8/6/09 to its customers informing them of the problem and the need to have a yoke back-up plate installed on the Manifold Block Assembly.
Distribution Pattern Nationwide distribution.
Code Information / Serial Numbers All units of model numbers 8065-870 and 8066-910

Related Establishments / Registrations

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