FDA Medical Device Recalls (openFDA)
Cardinal Health 200, LLC: Enteral Infusion Pump
- Recall number
- Z-1347-2021
- Recalling firm
- Cardinal Health 200, LLC
- Product
- Enteral Infusion Pump
- Status
- Completed
- Initiated
- 2021-01-19
- Posted
- not on file
- Terminated
- not on file
- Reason
- The potential for air appearing in the enteral feed pumping set tubing during set-up.
- Root cause
- Process control
- Action
- On 03/01/2021, Cardinal Health issued an Urgent Medical Device Correction notice to customers via letter to the potential of air entering the feed set tubing of enteral fusion pumps with the specified product codes
- Quantity
- 146,944,334 units
- Distribution
- Domestic: All 50 states and DC, Foreign: Argentina, Australia, Brazil, Canada, Chile, Colombia, Japan, Mexico, Netherlands, Panama, Peru, Puerto Rico, Singapore, Switzerland, Turkey
- Lot, serial or model codes
- Catalog Number: 612054, 613650, 614650, 672055, 673656, 673662, 674655, 674668, 674669, 716154, 762055, 763656, 763662, 765100, 765559, 772055, 773656, 773662, 775100, 775659, 776150
- 510(k) numbers
- ["K040196"]
- PMA numbers
- not on file
- Product code
- LZH
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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