Cardinal Health Recalls Femoral Angiography Drapes Due to Sticking Defect
Cardinal Health is recalling non-sterile femoral angiography drapes because a manufacturing defect causes them to stick, preventing proper application.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states no illnesses or injuries have been reported. The hazard is a functional defect (sticking) that prevents proper application, which fits the criteria for a moderate severity recall involving a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Cardinal Health 200, LLC is recalling 83,213 units of non-sterile Femoral Angiography Drape Bulk products. The recall is due to a manufacturing variance in the plastic film used to manufacture the products, which causes the drapes and leggings to stick. This defect may prevent the products from being unfolded and applied properly.
The affected products were distributed nationwide to 47 states and the District of Columbia, as well as to Australia and Canada. The specific catalog number is 29560NC, and the recall includes multiple lot numbers ranging from 2450ER1 to 2950ER2.
Healthcare facilities and consumers should stop using these products and contact Cardinal Health for instructions on how to return them or obtain a replacement. The source text does not report any illnesses or injuries associated with this defect.
The recalled product
- Product
- Femoral Angiography Drape Bulk Non-Sterile
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Drapes
- Affected units
- 83,213
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 (20)
- Catalog Number 29560NC
- Lot number's: 2450ER1
- 2660ER1
- 2960ER1
- 2450ER2
- 2660ER2
- 2960ER2
- 2460ER1
- 2670ER1
- 2970ER1
- 2460ER2
- 2670ER2
- 2970ER2
- 2470ER1
- 2690ER1
- 3030ER1
- 2470ER2
- 2690ER2
- 3030ER2
- 2480ER1
Distribution
Part of a larger recall action
This product is one of 5 recalled by Cardinal Health 200, LLC 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.
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