FDA Medical Device Recalls (openFDA)
Cardinal Health 200, LLC: 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.
- Recall number
- Z-2038-2021
- Recalling firm
- Cardinal Health 200, LLC
- 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.
- Status
- Terminated
- Initiated
- 2021-05-21
- Posted
- not on file
- Terminated
- 2024-01-08
- Reason
- The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-sterile configurations.
- Root cause
- Nonconforming Material/Component
- Action
- The firm initiated the recall by letter on 05/20/2021. The letter explained the issue and the hazard, and requested the return of the units.
- Quantity
- 15360 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- 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, 3320LR1, 3350LR1, 3390LR1, 3420LR1
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PUI
- Firm FEI
- 3001236905
- Firm city
- Waukegan
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28