Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped see related information
Date Initiated by Firm November 20, 2015
Create Date December 14, 2015
Recall Status1 Terminated 3 on August 22, 2016
Recall Number Z-0415-2016
Recall Event ID 72682
510(K)Number K142539  
Product Classification Gastrointestinal Tubes with Enteral Specific Connectors - Product Code PIF
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.
Code Information All EnteraLite Infinity Enteral Pump Delivery Sets with ENFit connector System and transitional Stepped Connector.
Recalling Firm/
Manufacturer		 MOOG Medical Devices Group
4314 S Zevex Park Ln
Salt Lake City UT 84123-7881
For Additional Information Contact Christopher Dodge
801-264-1001
Manufacturer 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.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action 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.
Quantity in Commerce 12,014,130 sets
Distribution Distributed to the state of MN.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = PIF and Original Applicant = ZEVEX, INC.
-
-