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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm December 18, 2015
Create Date March 09, 2016
Recall Status1 Terminated 3 on August 17, 2016
Recall Number Z-1080-2016
Recall Event ID 72961
510(K)Number K792125  
Product Classification Stopcock, i.V. Set - Product Code FMG
Product Custom Assembly, Custom FCFFM x/8.2 cm Tubing Extension, Model Number: FCA026-001, Manufactured by: Value Plastics dba Nordson MEDICAL, 805 West 71st Street, Loveland, CO 80538, packaged in Bags consisting of 100, 500 or 1,000 stopcocks.
Code Information Catalog #: FCA026-001  Lot #s: 67775, 69321, 69814, 70178, 71812, 152127, 152903, 153015 
Recalling Firm/
Manufacturer		 Value Plastics, Inc.
3325 S Timberline Rd
Fort Collins CO 80525-2903
For Additional Information Contact Jodi L. Raus
651-405-2183
Manufacturer Reason
for Recall		 Potential for the parts to crack.
FDA Determined
Cause 2		 Process control
Action Customers were initially notified by telephone call; followed by recall notice via email on 12/18/15. The recall letter instructs customers to identify their customers and notify them of the product recall. Returned product will be quarantined and separated from acceptable materials and scrapped.
Quantity in Commerce 33,000
Distribution 3 Consignees in NY, PA, MN. No foreign, VA/govt.
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 = FMG and Original Applicant = TRONOMED, INC.
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