Device Recall EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped 의 리콜

Recall

72682

Class 2

Z-0415-2016

2015-11-20

Terminated

United States

2016-08-22

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141973

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

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.