Infinity Orange Enteral Feeding Pump, REF INFORNG, Zevex Enteral Nutrition Delivery Systems, Salt Lake City, UT 84123.
FDA device recall Z-2113-2009 · posted 2009-09-21 · Terminated
Recall details
- Recalling firm
- Zevex International, Inc.
- Reason for recall
- Enteral feeding pumps may not accurately deliver fluid, potentially under-infusing or over-infusing.
- Action taken
- All of Zevex' customers and distributors were notified by an Urgent Medical Device Correction letter, dated 12/18/2008. The letters explained the issue, the patient impact, and what necessary actions should be taken. Customers were instructed to contact Zevex to schedule the upgrade of their installed base of pumps at 800-970-2337 or sales@zevex.com. Distributors were to contact their customers and notify them of the letter.
- Root cause
- Software design (manufacturing process)
- Status
- Terminated
- Product code
- LZH
- Quantity affected
- 318
- Distribution
- Nationwide, including 1 VA facility in CA. Foreign distribution to 1 consignee in Canada.
- Date initiated
- 2008-12-18
- Date posted
- 2009-09-21
- Date terminated
- 2011-10-27
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENTERALITE INFINITY ENTERAL FEEDING PUMP (K031199) | Zevex Intl., Inc. | 2003-07-09 |