CLASS II Device recall · Reported 23 Dec 2015 · FDA Enforcement Report
Catalog No. INF0020-A EnteraLite Infinity Enteral Pump recalled
Moog Medical Devices Group is recalling Catalog No. INF0020-A EnteraLite Infinity Enteral Pump Delivery Set, distributed in Minnesota. The recall was initiated on 20 Nov 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0415-2016
- FDA event ID
- 72682
- Recalling firm
- Moog Medical Devices Group, Salt Lake City, UT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Nov 2015
- FDA classified
- 14 Dec 2015
- Reported
- 23 Dec 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Masks, Gloves & PPE
Timeline
| 20 Nov 2015 | Recall initiated by company | |
| 14 Dec 2015 | Classified by FDA | +24 days |
| 23 Dec 2015 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for leaking between the purple ENFit connector and the white transitional stepped connector due to cracking or breaking of the purple connector.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Catalog No. INF0020-A EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector (spiked set); Catalog No. INF0500-A - 500ml EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector; Catalog No INF1200-A - 1200ml EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector; Catalog No GR1200-A 1200ml Enteral Feeding Delivery Set with ENFit Connector System and Transitional Stepped Connector (gravity set). Used to dispense liquid nutrients at a preprogrammed pump or user controlled rate.
Where it was distributed
Distributed to the state of MN.
Questions about this recall
Why was it recalled?
Potential for leaking between the purple ENFit connector and the white transitional stepped connector due to cracking or breaking of the purple connector.
Which lots are affected?
All EnteraLite Infinity Enteral Pump Delivery Sets with ENFit connector System and transitional Stepped Connector.
Where was it sold?
Distributed to the state of MN.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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