Angiography and Cesarean Birth Drapes recalled due to sticking defect
Cardinal Health is recalling Nonsterile Femoral Angiography and Cesarean Birth Drapes (15,360 units) because plastic film causes sticking that may prevent proper unfolding and 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 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 medical device recall involving protective surgical drapes with a manufacturing defect that prevents proper application, creating risk of microbial contamination during surgical procedures. No illnesses or injuries have been reported.
Plain-English summary
Cardinal Health 200, LLC is recalling Nonsterile Femoral Angiography Drapes and Cesarean Birth Drapes with Catalog Numbers 29460NB and 29456NB. These products are protective patient coverings designed to isolate surgical incision sites from microbial and other contamination.
The plastic film used in manufacturing these drapes is causing them to stick, which may prevent the products from being unfolded and applied properly. This defect could compromise the protective function of the drapes during surgical procedures.
The recall affects 15,360 units distributed nationwide. Specific lot numbers are identified for both catalog numbers. Healthcare facilities and surgical centers should check their inventory of these products against the provided lot numbers.
Healthcare providers using affected drapes should discontinue use immediately and contact Cardinal Health regarding replacement products.
The recalled product
- Product
- Nonsterile Femoral Angiography Drape, Catalog Numbers: a) 29460NB, b) 29456NB - 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 Drape
- Affected units
- 15,360
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)
- a) 29460NB: Lot Numbers: 0071PR1
- 0121PR1
- 0131PR1
- 0141PR1
- 0271PR1
- 0281PR1
- 0291PR1
- 0351PR1
- 0361PR1
- 0391PR1
- 0401PR1
- 3040PR1
- 3110PR1
- 3250PR1
- 3380PR1
- 3510PR1
- 3520PR1
- 3530PR1 b) 29456NB: Lot Numbers: 3290LR1
- 3300LR1
- 3310LR1
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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