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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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…"
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 →- SevereCardinal Health Recalls Presource Anesthesia Circuit Kits Due to Airflow Obstruction Risk
FDA (Devices) · 2013-05-15
- SevereCardinal Health Recalls Presource Total Hip Kits Due to Airflow Risk
FDA (Devices) · 2013-05-15
- SevereCardinal Health Recalls Presource Knee Arthroscopy Kits Due to Airflow Obstruction Risk
FDA (Devices) · 2013-05-15
- SevereCardinal Health Recalls Presource Knee Arthroscopy Kits Due to Airflow Obstruction Risk
FDA (Devices) · 2013-05-15
- SevereCardinal Health Recalls Presource PBDS Kits Due to Airflow Obstruction Risk
FDA (Devices) · 2013-05-15
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FDA (Devices) · 2018-08-15
- SevereVyaire Medical Recalls Pediatric AirLife Resuscitation Devices Due to Airflow Obstruction Risk
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