Cardinal Health Recalls Presource Shoulder Procedure Kits Due to Airflow Risk
Cardinal Health is recalling 4,571 Presource Shoulder Procedure 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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states the agency classification is Class I, which mandates a score of 5 per the rubric.
Plain-English summary
Cardinal Health, Medical Products & Services is recalling 4,571 Presource PBDS, Shoulder Procedure, Kit, Circulator units. The recall is due to a potential defect where outer plastic packaging on components may leave remnants in the filter if removed without disassembling the parts. This can cause an obstruction of airflow.
The affected kits are identified by Catalog Number PO24SHNPC01 and Lots 843685, 864636, 875004, 893118, 901720, 924132, 934399, 959120, and 968668. These products were distributed in the states of Arkansas, Mississippi, South Carolina, and Tennessee.
The U.S. Food and Drug Administration has classified this as a Class I recall. Users should stop using the affected kits and contact Cardinal Health for instructions on return or replacement.
The recalled product
- Product
- Presource PBDS, Shoulder Procedure, Kit, Circulator
- Manufacturer
- Cardinal Health, Medical Products & Services
- Category
- Medical Device — Surgical Kits
- 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 (10)
- Catalog Number: PO24SHNPC01
- Lots: 843685
- 864636
- 875004
- 893118
- 901720
- 924132
- 934399
- 959120
- 968668
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
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