Recall Z-0764-2013 ยท LZH Pump, Infusion, Enteral
MOOG Medical Devices Group
Infinity Enteralite Ambulatory Feeding Pumps, List number: INFKIT2 - Addendum to Operator's Manual Product usage: provide a means for the volumetric delivery of fluids used in Enteral applications.
| Date | Jan 31, 2013 (initiated Oct 12, 2012) |
| Status | Terminated |
| Reason | The firm is adding an addendum to the operator's manual for Infinity Enteralite Ambulatory Feeding Pumps pertaining to the Infinite Dose mode and the inability of the Pump to detect air in line. |
| Root cause | Nonconforming Material/Component |
| Action | An Urgent Field Safety Notice was sent to all original consignees by certified mail beginning on Monday, October 15, 2012. Consignees were provided with an Addendum to the Operator's Manual as part of the Notice. Consignees were instructed to assure pump users are aware of the information in the addendum and to store the addendum with the Operator's Manual. Consignees were also requested to complete and return a Medical Device Recall reply form to the firm. For additional information or clarification, consignees are to contact Holly Imes, Manager, Regulatory Affairs at 801-264-1001, ext. 2 |
| Quantity | 92,488 units |
| Distribution | Worldwide Distribution and US Nationwide in the countries of (Germany, Sweeden, Croatia, Lithuania, and Dubai). |
| 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 |