Compat Enteral Delivery Pump Set with Piercing Spike, Item number 19930700
FDA device recall Z-0607-03 · posted 2003-03-05 · Terminated
Recall details
- Recalling firm
- Novartis Nutrition Corp
- 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.
- Action taken
- The recall letter, dated January 31, 2003, requested that the consignees return the recalled products and notify 'end users' to stop using the products.
- Root cause
- Other
- Status
- Terminated
- Product code
- LZH
- Quantity affected
- 114 cases (30 tube sets per case)
- Distribution
- Nationwide in the United States and to Canada
- Date initiated
- 2003-01-27
- Date posted
- 2003-03-05
- Date terminated
- 2004-06-24
- Location
- St Louis Park, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SANDOZ NUTRITION COMPAT(R) ENTERAL FEEDING PUMP (K940556) | Sandoz Nutrition | 1994-11-07 |