FDA Medical Device Recalls (openFDA)
Abbott Laboratories: Flexiflo Quantum Pump Set with Piercing Pin and Flush Bag The product is used with Quantum pump to deliver ready-to-hang (RTH) product in enterally-fed patients.
- Recall number
- Z-2305-2008
- Recalling firm
- Abbott Laboratories
- Product
- Flexiflo Quantum Pump Set with Piercing Pin and Flush Bag The product is used with Quantum pump to deliver ready-to-hang (RTH) product in enterally-fed patients.
- Status
- Terminated
- Initiated
- 2008-06-27
- Posted
- 2008-09-20
- Terminated
- 2012-09-19
- Reason
- Product was incorrectly labeled as "Top-Fill Enteral Nutrition Bag" instead of "Flexiflo Quantum Pump Set."
- Root cause
- Labeling mix-ups
- Action
- On June 27, 2008, the firm sent Important Device Recall letters to their customers. The letter instructed their customers to immediately inspect their inventory for the affected product, place it on hold, and report the information to back to them via account summary forms. Furthermore, if they are a distributor, they are required to contact their customers and notify them of this important device recall and supply them with the appropriate documentation to record the recall. Contact Abbott Nutrition, Abbott Laboratories at 1-614-624-3688 for assistance.
- Quantity
- 57,120 units
- Distribution
- Nationwide: AR, AZ, CA, CO, CT, FL, IA, ID, IL, IN, KS, KY, LA, MA, MI, MO, MS, NH, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, VT, WA, WI and WY.
- Lot, serial or model codes
- List #50604 Lot #47822RY Use By DEC 2009
- 510(k) numbers
- ["K915735"]
- PMA numbers
- not on file
- Product code
- LZH
- Firm FEI
- 1513768
- 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