Z-0608-03

Compat 500 mL Baggle Top Fill Enteral Feeding Container with Preattached Enteral Delivery Pump Set, Item...

Name: Z-0608-03 Compat 500 mL Baggle Top Fill Enteral Feeding Container with Preattached Enteral Delivery Pump Set, Item...
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 500 mL Baggle Top Fill Enteral Feeding Container with Preattached Enteral Delivery Pump Set, Item number 19931200 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-0608-03
Status: Terminated
Initiated: 2003-01-27
Posted: 2003-03-05
Terminated: 2004-06-24
Recalling firm: Novartis Nutrition Corp.
Product: Compat 500 mL Baggle Top Fill Enteral Feeding Container with Preattached Enteral Delivery Pump Set, Item number 19931200
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: 803 cases (30 tube sets per case)
Distribution: Nationwide in the United States and to Canada
Product codes and lots: Item number 19931200, lots 3152A and 3182A

Product code LZH

K940556Class IISandoz Nutrition Compat(r) Enteral Feeding PumpSandoz Nutrition / cleared 1994-11-07

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)