Device product
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.
Z-0415-2016
Product summary
- Event
- Event 72682
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12,014,130 sets
- Official record key
device-enforcement:Z-0415-2016
Official wording
Reason: Potential for leaking between the purple ENFit connector and the white transitional stepped connector due to cracking or breaking of the purple connector.
Code information: All EnteraLite Infinity Enteral Pump Delivery Sets with ENFit connector System and transitional Stepped Connector.
Distribution pattern: Distributed to the state of MN.
Derived failure modes
-
Unknown
Potential for leaking between the purple ENFit connector and the white transitional stepped connector due to cracking or breaking of the purple connector.