Z-1204-2013 Class I Terminated
FDA device recall Z-1204-2013 was initiated by Cardinal Health, Medical Products & Services on March 26, 2013 and is designated Class I. Reason for recall: 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 c… The recall status is terminated (terminated April 12, 2017). Affected quantity: 4,571 Kits total.
Recall Details
- Product Type
- Devices
- Report Date
- May 15, 2013
- Initiation Date
- March 26, 2013
- Termination Date
- April 12, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,571 Kits total
Product Description
Presource PBDS, Total Knee, Kit, Circulator
Reason for Recall
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.
Distribution Pattern
Distributed in the states of AR, MS, SC, and TN.
Code Information
Catalog Number: PO24TKGWE01; Lots: 828654, 851596, 872322, 879459, 885132, 905305, 920462, 934298, 946652, 959208