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Terminated

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 volumetric delivery of fluids used in enteral applications.

FDA Recall Z-0294-2013 · Posted 2012-11-15

Recall StatusTerminated
Product CodeLZH
Date Initiated2012-11-08
Date Terminated2014-01-30
Product Quantity8,736

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.

Firm 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. 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

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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