Recall Z-0294-2013 ยท LZH Pump, Infusion, Enteral
MOOG Medical Devices Group
EnteraLite Infinity Enteral Feeding Pump identified with the following list numbers: INFKIT2 and INFORNG. The device is used with disposable PVC administration tubing sets to provide a means for the volumetric delivery of fluids used in enteral applications. The EnteraLite Infinity enteral feeding pump with disposable PVC administration tubing sets and user accessories provide a means for the vo
| Date | Nov 15, 2012 (initiated Nov 8, 2012) |
| Status | Terminated |
| Reason | MOOG Medical Devices Group is conducting a voluntary for a limited set of serial numbers of the EnteraLite Infinity and Infinity Orange Small Volume Enteral Feeding Pumps because certain diodes on the PCB assembly may result in insufficient voltage to a portion of the pump resulting in an error 13 message and shutting the pump down entirely. |
| Root cause | Component design/selection |
| Action | MOOG Medical Devices Group sent a Urgent Medical Device Recall letter dated November 8, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to contact Moog Medical Devices Group to discuss the process for product replacement at 1-800-970-2337, prompt #7. See Attachment A to determine if you have a serial number that is related to a suspect pump. Determine the number of affected pumps. Notify all of your affected customers of the recall and the protocol for getting a replacement pump. Pro |
| Quantity | 8,736 |
| Distribution | Worldwide Distribution - USA (nationwide) including the countries of Canada and Lithuania. |
| 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 |