Recall Z-0608-03 ยท LZH Pump, Infusion, Enteral
Novartis Nutrition Corp
Compat 500 mL Baggle Top Fill Enteral Feeding Container with Preattached Enteral Delivery Pump Set, Item number 19931200
| 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 | 803 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
| K940556 | SANDOZ NUTRITION COMPAT(R) ENTERAL FEEDING PUMP Sandoz Nutrition, Nov 7, 1994 |