FDA Medical Device Recalls (openFDA)
Novartis Nutrition Corp: Compat DualFlo Enteral Delivery Pump Set with 1000-mL Twist Cap Formula Vinyl Bag and 1000-mL Twist Cap Water Bag, Item number 19944700
- Recall number
- Z-0609-03
- 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
- Status
- Terminated
- Initiated
- 2003-01-27
- Posted
- 2003-03-05
- Terminated
- 2004-06-24
- Reason
- 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.
- 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
- 11 cases (30 tube sets per case)
- Distribution
- Nationwide in the United States and to Canada
- Lot, serial or model codes
- Item number 19944700, lot 3232E
- 510(k) numbers
- ["K940555"]
- PMA numbers
- not on file
- Product code
- LZH
- Firm FEI
- 2110851
- Firm city
- St Louis Park
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28