Recall Z-2112-2009 ยท LZH Pump, Infusion, Enteral
Zevex International, Inc.
EnteraLite Infinity Enteral Feeding Pump, REF INFP01, Zevex Enteral Nutrition Delivery Systems, Salt Lake City, UT 84123. A rotary peristaltic pump designed to deliver programmed doses of enteral nutrition solutions at selectable rates.
| Date | Sep 21, 2009 (initiated Dec 18, 2008) |
| Status | Terminated |
| Reason | Enteral feeding pumps may not accurately deliver fluid, potentially under-infusing or over-infusing. |
| Root cause | Software design (manufacturing process) |
| Action | 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. |
| Quantity | 32,545 |
| Distribution | Nationwide, including 1 VA facility in CA. Foreign distribution to 1 consignee in Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031199 | ENTERALITE INFINITY ENTERAL FEEDING PUMP Zevex Intl., Inc., Jul 9, 2003 |