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Recall Observatory FDA recall evidence

Device product

Presource PBDS, Shoulder Procedure, Kit, Circulator

Z-1201-2013

March 26, 2013

Class I

Product summary

Firm
Cardinal Health, Medical Products & Services
Event
Event 64736
Status
Terminated
Classification
Class I
Quantity
4,571 Kits total
Official record key
device-enforcement:Z-1201-2013

Official wording

Reason: Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.

Code information: Catalog Number: PO24SHNPC01; Lots: 843685, 864636, 875004, 893118, 901720, 924132, 934399, 959120, 968668

Distribution pattern: Distributed in the states of AR, MS, SC, and TN.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.