Nonsterile Femoral Angiography Drapes Recalled Due to Sticking Plastic Film Defect
Cardinal Health is recalling 26,250 units of Nonsterile Femoral Angiography Drapes due to a manufacturing defect causing the drapes to stick and preventing proper application. This may compromise surgical site protection.
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: FDA Class II recall of a medical device designed to prevent surgical site contamination. While no illnesses or injuries have been reported, the product's failure to unfold and apply properly creates a risk of surgical site infection, meeting the criterion for Score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cardinal Health 200, LLC is recalling 26,250 units of Nonsterile Femoral Angiography Drape with Single Pouch (Catalog Number 29525N) distributed nationwide. These drapes are intended for use as protective patient coverings during surgical procedures to isolate surgical incision sites from microbial contamination.
A defect in the plastic film used to manufacture these drapes causes them to stick together, preventing proper unfolding and application. This functional failure may prevent the drapes from being used as intended to protect surgical sites during femoral angiography and cesarean birth procedures.
Healthcare facilities should check their inventory using the 21 provided lot numbers and cease use of affected units. Facilities should consult with Cardinal Health and the FDA regarding replacements or further guidance. No illnesses or injuries have been reported to date.
The recalled product
- Product
- Nonsterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525N - 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
- Category
- Medical Device — Surgical Drapes
- Affected units
- 26,250
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)
- Lot Numbers: 0141ER1
- 0141ER2
- 2400ER2
- 2410ER1
- 2410ER2
- 2540ER2
- 2550ER1
- 2550ER2
- 2580ER1
- 2580ER2
- 2590ER1
- 2590ER2
- 2600ER1
- 2760ER2
- 2880ER1
- 2940ER1
- 2940ER2
- 3070ER1
- 3080ER1
- 3530ER1
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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