Cardinal Health Recalls Presource PBDS Extremity Circulator Kits
Cardinal Health is recalling 4,571 Presource PBDS Extremity Circulator Kits because plastic packaging remnants may obstruct airflow.
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 classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
Cardinal Health, Medical Products & Services is recalling 4,571 Presource PBDS, Extremity, Kit, Circulator units. The recall involves catalog number PO24EXNPD01 and specific lots: 852429, 868825, 883022, 896400, 914524, 929984, 941696, and 954317. 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.
The U.S. Food and Drug Administration has classified this recall as Class I. Consumers and healthcare providers should stop using the affected kits and contact Cardinal Health for further instructions.
The recalled product
- Product
- Presource PBDS, Extremity, 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 (9)
- Catalog Number: PO24EXNPD01
- Lots: 852429
- 868825
- 883022
- 896400
- 914524
- 929984
- 941696
- 954317
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
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