The Recall Desk
ModerateFDA (Devices)·Z-0764-2013·Announced 2013-02-06

MOOG Infinity Enteralite Feeding Pumps Recall for Manual Addendum

MOOG Medical Devices Group is recalling 92,488 Infinity Enteralite Ambulatory Feeding Pumps to add an operator's manual addendum regarding the Infinite Dose mode and air-in-line detection limitations.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific hazard involves a documentation update regarding a known limitation (air-in-line detection) rather than a reported injury or critical defect, fitting the Moderate category for a precautionary documentation recall.

Plain-English summary

MOOG Medical Devices Group is recalling 92,488 units of Infinity Enteralite Ambulatory Feeding Pumps (List number: INFKIT2). The recall is being conducted to add an addendum to the operator's manual for these devices.

The addendum addresses the Infinite Dose mode and notes the pump's inability to detect air in the line. The affected units were distributed worldwide and nationwide in the United States, with specific mentions of Germany, Sweden, Croatia, Lithuania, and Dubai.

Consumers and healthcare providers should check their device serial numbers against the list provided in the official recall notice. Users should consult the updated operator's manual addendum for instructions on the Infinite Dose mode and air-in-line detection limitations.

The recalled product

Product
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.
Affected units
92,488

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • List number: INFKIT2 Lot/Serial numbers: 105068015
  • 105068002
  • 105068014
  • 105068013
  • 105068012
  • 105068011
  • 105068009
  • 105068008
  • 105068007
  • 105066024
  • 105066021
  • 105068003
  • 105068005
  • 105068006
  • 105066004
  • 105068027
  • 105068028
  • 105068026
  • 105068019
  • 105068020

Distribution

Distributed nationwide across the United States.