Recall Z-1204-2013— Cardinal Health, Medical Products & Services
Class I · Terminated
Class I FDA medical device recall by Cardinal Health, Medical Products & Services, initiated 2013-03-26, terminated 2017-04-12. FDA's recall record names no specific 510(k) clearance for this event. Product: Presource PBDS, Total Knee, Kit, Circulator. 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..
- Recalling firm
- Cardinal Health, Medical Products & Services
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2013-03-26
- Terminated
- 2017-04-12
- Firm location
- Park City, IL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.