FDA Medical Device Recalls (openFDA)
Ross Products Division Abbott Laboratories: Flexiflo Quantum Enteral Pump
- Recall number
- Z-0570-05
- Recalling firm
- Ross Products Division Abbott Laboratories
- Product
- Flexiflo Quantum Enteral Pump
- Status
- Terminated
- Initiated
- 2004-08-18
- Posted
- 2005-03-08
- Terminated
- 2012-04-12
- Reason
- Pumps were manufactured with an incorrect circuit board that may cause an increase in the feed rate and flush frequency of fluids.
- Root cause
- Other
- Action
- The firm contacted all consignees via telephone and letter on 08/18/2004.
- Quantity
- 199 individual serial numbered units
- Distribution
- Products were distributed to the following states nationwide: MA, NJ, NY, PA, MD, VA, NC, SC, GA, FL, CA, TN, KY, OH, MI, SD, IL, KS, LA, AR, OK, TX, and CO.
- Lot, serial or model codes
- Serial #1061305 through 1061455 Serial #1061486 through 1061505 Serial #1061507 through 1061512 Serial #1061705 through 1061726
- 510(k) numbers
- ["K944669"]
- PMA numbers
- not on file
- Product code
- LZH
- Firm FEI
- 1000136098
- 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