FDA Medical Device Recalls (openFDA)
Abbott Laboratories: Fleixiflo Quantum Enteral Pump.
- Recall number
- Z-0145-06
- Recalling firm
- Abbott Laboratories
- Product
- Fleixiflo Quantum Enteral Pump.
- Status
- Terminated
- Initiated
- 2005-10-07
- Posted
- 2005-11-16
- Terminated
- 2007-08-13
- Reason
- Pumps have the potential to malfunction and result in a significant over-under delivery of enteral formula.
- Root cause
- Other
- Action
- The recalling firm notified consignees by phone on 10/7/05 and followed up by letter dated 10/7/05.
- Quantity
- 24 devices
- Distribution
- The device was distributed to 11 hospitals, 5 medical supply customers, and 3 nursing homes located in AL, CA, IN, LA, MI, NC, NH, NY, OH, OK, PA, SC, TN, VA, and WI.
- Lot, serial or model codes
- Serial numbers 1003276, 1022603, 1025074, 1027378, 1028541, 1049161, 1056343, 1056908, 1057323, 1057967, 1058939, 1059103, 1059366, 1059614, 1059641, 1059857, 1059892, 1059945, 1060026, 1060188, 1061131, 1061355, 1061492.
- 510(k) numbers
- ["K944669"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 1527460
- Firm city
- Columbus
- Firm state
- OH
- 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