Z-0570-05

Flexiflo Quantum Enteral Pump

Name: Z-0570-05 Flexiflo Quantum Enteral Pump
Creator: Ross Products Division Abbott Laboratories
Published: 2004-08-18
License: https://open.fda.gov/license/

Ross Products Division Abbott Laboratories / initiated 2004-08-18 / Terminated / root cause: manufacturing process

FDA source

Ross Products Division Abbott Laboratories began a recall of Flexiflo Quantum Enteral Pump on 2004-08-18. The reason FDA records is "Pumps were manufactured with an incorrect circuit board that may cause an increase in the feed rate and flush frequency of fluids". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0570-05
Status: Terminated
Initiated: 2004-08-18
Posted: 2005-03-08
Terminated: 2012-04-12
Recalling firm: Ross Products Division Abbott Laboratories
Product: Flexiflo Quantum Enteral Pump
Product code: LZH Pump, Infusion, Enteral
Reason for recall: Pumps were manufactured with an incorrect circuit board that may cause an increase in the feed rate and flush frequency of fluids.
Root cause tag: manufacturing process
FDA root cause: Other
Action: The firm contacted all consignees via telephone and letter on 08/18/2004.
Quantity in commerce: 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.
Product codes and lots: Serial #1061305 through 1061455 Serial #1061486 through 1061505 Serial #1061507 through 1061512 Serial #1061705 through 1061726

Product code LZH

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)