EnteraLite Infinity Enteral Feeding Pump identified with the following list numbers: INFKIT2 and INFORNG. The device is

FDA device recall Z-0294-2013 · posted 2012-11-15 · Terminated

Recall details

Recalling firm

MOOG Medical Devices Group

Reason for recall

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.

Action taken

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. Provide serial numbers, number of product(s) to be returned and a shipping address for replacement product. Execute the pump replacement process discussed in the conversation with Moog Customer Advocacy. Package and return product via shipping label.

Root cause

Component design/selection

Status

Terminated

Product code

LZH

Quantity affected

8,736

Distribution

Worldwide Distribution - USA (nationwide) including the countries of Canada and Lithuania.

Date initiated

2012-11-08

Date posted

2012-11-15

Date terminated

2014-01-30

Location

Salt Lake City, UT

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