Recall Z-0609-03 ยท LZH Pump, Infusion, Enteral
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
| Date | Mar 5, 2003 (initiated Jan 27, 2003) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K940555 | SANDOZ NUTRITION COMPAT ENTERAL FEED PUMP W/HYDRATION Sandoz Nutrition, Feb 1, 1995 |