Cardinal Health Recalls Presource Total Knee Kits Due to Airflow Obstruction Risk
Cardinal Health is recalling 4,571 Presource Total Knee Kits because plastic packaging remnants may obstruct airflow in the filter.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a defect (airflow obstruction) poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Cardinal Health, Medical Products & Services is recalling 4,571 Presource PBDS, Total Knee, Kit, Circulator units. The recall involves specific catalog number PO24TKGWE01 and lots 828654, 851596, 872322, 879459, 885132, 905305, 920462, 934298, 946652, and 959208. These kits were distributed in the states of Arkansas, Mississippi, South Carolina, and Tennessee.
The recall was initiated because the kits contain a pre-assembled Filter and Anesthesia Circuit that may have outer plastic packaging on one or more components. If this packaging is removed without disassembling the components, remnants of the plastic may become lodged in the filter. This can potentially cause an obstruction of airflow.
Healthcare facilities and consumers should stop using these specific kits and contact Cardinal Health for instructions on return or replacement. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Presource PBDS, Total Knee, Kit, Circulator
- Manufacturer
- Cardinal Health, Medical Products & Services
- Affected units
- 4,571
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- Catalog Number: PO24TKGWE01
- Lots: 828654
- 851596
- 872322
- 879459
- 885132
- 905305
- 920462
- 934298
- 946652
- 959208
Distribution
Part of a larger recall action
This product is one of 14 recalled by Cardinal Health, Medical Products & Services under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 14 products in this recall →Related recalls
Same manufacturer · Cardinal Health, Medical Products & Services
See all →- ModerateCardinal Health Recalls Presource Total Hip Kits Due to Airflow Risk
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- SevereCardinal Health Recalls Presource Knee Arthroscopy Kits Due to Airflow Obstruction Risk
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- HighCardinal Health Recalls Presource Anesthesia Circuit Kits Due to Airflow Obstruction Risk
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- HighCardinal Health Recalls Presource Knee Arthroscopy Kits Due to Airflow Obstruction Risk
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- SevereCardinal Health Recalls Presource PBDS Kits Due to Airflow Obstruction Risk
FDA (Devices) · 2013-05-15
Same hazard · airflow obstruction
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