CLASS I Device recall · Reported 15 May 2013 · FDA Enforcement Report
Presource PBDS, Total Hip, Kit, Circulator recalled
Cardinal Health, Medical Products & Services is recalling Presource PBDS, Total Hip, Kit, Circulator, distributed in Arkansas, Mississippi, South Carolina, Tennessee. The recall was initiated on 26 Mar 2013 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1202-2013
- FDA event ID
- 64736
- Recalling firm
- Cardinal Health, Medical Products & Services, Park City, IL
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 26 Mar 2013
- FDA classified
- 3 May 2013
- Reported
- 15 May 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Hip & Knee Implants
Timeline
| 26 Mar 2013 | Recall initiated by company | |
| 3 May 2013 | Classified by FDA | +38 days |
| 15 May 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Presource PBDS, Total Hip, Kit, Circulator
Where it was distributed
Distributed in the states of AR, MS, SC, and TN.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Catalog Number: PO24THGWG01; Lots: 966051, 970753
Where was it sold?
Distributed in the states of AR, MS, SC, and TN.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
13 other products · FDA event 64736This product is part of a recall event; the main page for the event is Presource PBDS, Shoulder Procedure, Kit, Circulator recalled.
More recalls from Cardinal Health, Medical Products & Services
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