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Recall Observatory FDA recall evidence

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

November 20, 2015

Class II

Product summary

Firm
MOOG Medical Devices Group
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

    reason.no_named_rule · v1.0.0

    Potential for leaking between the purple ENFit connector and the white transitional stepped connector due to cracking or breaking of the purple connector.