MOOG Recalls EnteraLite Infinity Enteral Feeding Pumps Due to Voltage Defect
MOOG Medical Devices Group is voluntarily recalling specific EnteraLite Infinity enteral feeding pumps because a PCB defect may cause the device to shut down.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a medical device shutting down, which poses a risk of harm to patients relying on enteral feeding, but the source text does not report any injuries or illnesses.
Plain-English summary
MOOG Medical Devices Group is conducting a voluntary recall of a limited set of serial numbers for the EnteraLite Infinity and Infinity Orange Small Volume Enteral Feeding Pumps. The recall involves 8,736 units distributed nationwide in the United States, as well as in Canada and Lithuania.
The recall is being issued because certain diodes on the printed circuit board (PCB) assembly may result in insufficient voltage to a portion of the pump. This defect can cause the pump to display an error 13 message and shut down entirely. The source text does not report any illnesses or injuries associated with this defect.
Users of these devices should check their pump's serial number against the list provided by the manufacturer to determine if their unit is affected. If the serial number matches, users should contact MOOG Medical Devices Group for instructions on how to proceed with the recall.
The recalled product
- Product
- 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…
- Manufacturer
- MOOG Medical Devices Group
- Affected units
- 8,736
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)
- INFKIT2 with serial numbers: 506249031
- 506264096
- 506272024
- 506335006
- 506335145
- 506336089
- 506336096
- 506362083
- 506362086
- 507018037
- 507018060
- 507067220
- 507085140
- 507087018
- 507087140
- 507095089
- 507095171
- 507121102
- 507122050
- 507122066
Distribution
Distributed nationwide across the United States.
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