Recall Z-0415-2016— MOOG Medical Devices Group

Name: FDA recall Z-0415-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-20

Class II · Terminated

Class II FDA medical device recall by MOOG Medical Devices Group, initiated 2015-11-20, terminated 2016-08-22. It names one FDA 510(k) clearance: K142539. 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.. Reason: Potential for leaking between the purple ENFit connector and the white transitional stepped connector due to cracking or breaking of the purple connector..

Recalling firm: MOOG Medical Devices Group
Classification: Class II
Status: Terminated
Initiated: 2015-11-20
Terminated: 2016-08-22
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K142539 — EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery SetZevex, Inc.·cleared 2015-01-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.