Z-0415-2016 Class II Terminated
FDA device recall Z-0415-2016 was initiated by MOOG Medical Devices Group on November 20, 2015 and is designated Class II. 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. The recall status is terminated (terminated August 22, 2016). Affected quantity: 12,014,130 sets.
Recall Details
- Product Type
- Devices
- Report Date
- December 23, 2015
- Initiation Date
- November 20, 2015
- Termination Date
- August 22, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,014,130 sets
Product Description
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.
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 Pattern
Distributed to the state of MN.
Code Information
All EnteraLite Infinity Enteral Pump Delivery Sets with ENFit connector System and transitional Stepped Connector.