Z-0609-03

Compat DualFlo Enteral Delivery Pump Set with 1000-mL Twist Cap Formula Vinyl Bag and 1000-mL Twist Cap Water...

Name: Z-0609-03 Compat DualFlo Enteral Delivery Pump Set with 1000-mL Twist Cap Formula Vinyl Bag and 1000-mL Twist Cap Water...
Creator: Novartis Nutrition Corp
Published: 2003-01-27
License: https://open.fda.gov/license/

Novartis Nutrition Corp. / initiated 2003-01-27 / Terminated

FDA source

Novartis Nutrition Corp began a recall of Compat DualFlo Enteral Delivery Pump Set with 1000-mL Twist Cap Formula Vinyl Bag and 1000-mL Twist Cap Water Bag, Item number 19944700 on 2003-01-27. The reason FDA records is "Some of the sets may leak or disconnect near the pump adapter during use. The patient could ingest air and vomit causing a safety concern". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0609-03
Status: Terminated
Initiated: 2003-01-27
Posted: 2003-03-05
Terminated: 2004-06-24
Recalling firm: Novartis Nutrition Corp.
Product: Compat DualFlo Enteral Delivery Pump Set with 1000-mL Twist Cap Formula Vinyl Bag and 1000-mL Twist Cap Water Bag, Item number 19944700
Product code: LZH Pump, Infusion, Enteral
Reason for recall: Some of the sets may leak or disconnect near the pump adapter during use. The patient could ingest air and vomit causing a safety concern.
FDA root cause: Other
Action: The recall letter, dated January 31, 2003, requested that the consignees return the recalled products and notify 'end users' to stop using the products.
Quantity in commerce: 11 cases (30 tube sets per case)
Distribution: Nationwide in the United States and to Canada
Product codes and lots: Item number 19944700, lot 3232E

Product code LZH

K940555Class IISandoz Nutrition Compat Enteral Feed Pump W/hydrationSandoz Nutrition / cleared 1995-02-01

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)