Z-0145-06

Fleixiflo Quantum Enteral Pump

Name: Z-0145-06 Fleixiflo Quantum Enteral Pump
Creator: Abbott Laboratories
Published: 2005-10-07
License: https://open.fda.gov/license/

Abbott Medical / initiated 2005-10-07 / Terminated

FDA source

Abbott Laboratories began a recall of Fleixiflo Quantum Enteral Pump on 2005-10-07. The reason FDA records is "Pumps have the potential to malfunction and result in a significant over-under delivery of enteral formula". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0145-06
Status: Terminated
Initiated: 2005-10-07
Posted: 2005-11-16
Terminated: 2007-08-13
Recalling firm: Abbott Medical
Product: Fleixiflo Quantum Enteral Pump.
Product code: FRN Pump, Infusion
Reason for recall: Pumps have the potential to malfunction and result in a significant over-under delivery of enteral formula.
FDA 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 in commerce: 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.
Product codes and lots: 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.

Product code FRN

K944669Class IIFlexiflo Quantum Enteral PumpAbbott Mfg., Inc. / cleared 1995-07-24

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)