Sterile Femoral Angiography Drape Recall Due to Sticking Plastic Film
Cardinal Health is recalling sterile femoral angiography drapes because the plastic film causes drapes to stick, which may prevent proper unfolding and application during procedures.
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 3/5 (High).
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: This is a risk-of-harm medical device recall where drape failure could compromise sterile field integrity during surgical procedures. No injuries have been reported, but the potential for infection or surgical complications exists if the drape cannot be properly deployed.
Plain-English summary
Cardinal Health 200, LLC is recalling Sterile Femoral Angiography Drapes with catalog numbers 29460 and 29456. These drapes are intended to be used as protective patient coverings to isolate the surgical incision site from microbial and other contamination.
The plastic film used to manufacture these drapes is causing them to stick, which may prevent the products from being unfolded and applied properly. This issue affects approximately 5,342 units that were distributed nationwide in both single sterile and bulk non-sterile configurations.
Healthcare facilities that have received these drapes should stop using them and contact Cardinal Health for replacement. Patients who have had procedures using these affected drapes should consult their healthcare provider if they have concerns about their surgical site.
The recalled product
- Product
- Sterile Femoral Angiography Drape, Catalog Numbers: a) 29460, b) 29456 - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
- Manufacturer
- Cardinal Health 200, LLC
- Affected units
- 5,342
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 (3)
- a) 29460: Lot Numbers: 20LRS055
- 20MRS073
- 21ARS042 b) 29456: Lot Numbers: 20MMR062
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 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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