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.
This recall has been terminated (originally issued November 20, 2015).
- Company
- Moog Medical Devices Group
- Recall Initiated
- November 20, 2015
- Terminated
- August 22, 2016
- Recall Number
- Z-0415-2016
- Quantity
- 12,014,130 sets
- Firm Location
- Salt Lake City, UT
- Official Source
- View on FDA website ↗
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.
Distribution
Distributed to the state of MN.
Lot / Code Info
All EnteraLite Infinity Enteral Pump Delivery Sets with ENFit connector System and transitional Stepped Connector.
Root Cause
Unknown/Undetermined by firm
Action Taken
MOOG Medical sent an URGENT Field Safety Notice, dated November 20, 2015, to its customer. The letter identified the affected device, provided a description of the problem, and discussed the risk to health. The customer was asked to contact all known distributors and inform them that MOOG Medical will cease production of all its enteral administration sets using ENFit connectors and transition back to the previous revision of the product codes that do not include the ENFit connector (INF0020, INF0500, INF1200, and GR1200). MOOG Medical will produce the previous revision until a solution to the problem is found. All necessary users should be made aware of the notice. Christopher Dodge, Manager, Regulatory Affairs, should be contacted with questions or for additional info at 801-264-1001, ext. 112 or cdodge@moog.com.