Z-2305-2008

Flexiflo Quantum Pump Set with Piercing Pin and Flush Bag The product is used with Quantum pump to deliver...

Name: Z-2305-2008 Flexiflo Quantum Pump Set with Piercing Pin and Flush Bag The product is used with Quantum pump to deliver...
Creator: Abbott Laboratories
Published: 2008-06-27
License: https://open.fda.gov/license/

Abbott Medical / initiated 2008-06-27 / Terminated / root cause: labeling and UDI

FDA source

Abbott Laboratories began a recall of 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 on 2008-06-27. The reason FDA records is "Product was incorrectly labeled as "Top-Fill Enteral Nutrition Bag" instead of "Flexiflo Quantum Pump Set."". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2305-2008
Status: Terminated
Initiated: 2008-06-27
Posted: 2008-09-20
Terminated: 2012-09-19
Recalling firm: Abbott Medical
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.
Product code: LZH Pump, Infusion, Enteral
Reason for recall: Product was incorrectly labeled as "Top-Fill Enteral Nutrition Bag" instead of "Flexiflo Quantum Pump Set."
Root cause tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: List #50604 Lot #47822RY Use By DEC 2009

Product code LZH

K915735Class IIFlexiflo Quantum ENT. Pump Sets and ENT. Nut. ContAbbott Laboratories / cleared 1992-06-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)