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U.S. Department of Health and Human Services

Class 2 Device Recall CIVCO Medical Solutions

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  Class 2 Device Recall CIVCO Medical Solutions see related information
Date Initiated by Firm December 11, 2014
Date Posted January 15, 2015
Recall Status1 Terminated 3 on February 03, 2017
Recall Number Z-0990-2015
Recall Event ID 69997
Product Classification Restraint, protective - Product Code FMQ
Product Civco, MTSR03 Shoulder Retractor with Wrist Loops Kit with Base, plus two pairs of wrist loops (nylon and sherpa), Non-sterile re-usable wool wrist strap, REF: 20SR03, Rx

The devise is intended to pull patients shoulders down for clearance when treating lateral fields to the neck.
Code Information Lot: M612690 REF: 20SR03
Recalling Firm/
Med Tec Inc
1401 8th St SE
PO Box 320
Orange City IA 51041-7463
For Additional Information Contact James A. Leong
Manufacturer Reason
for Recall
The product (wool wrist loop) was manufactured 7cm shorter than product specifications.
FDA Determined
Cause 2
Component design/selection
Action The firm sent e-mailed Field Safety Notice letters and contacted customers via phone on December 11, 2014, informing customers of the issue with the product. Customers were advised they may accept the product as is or request a replacement. A response form was enclosed for consignees to indicate the status of the product. Please contact a CIVCO insides sales representative for additional assistance. You may reach your representative by calling CIVCO Medical Solutions, Radiation Oncology, at 800-842-8688 or 712-737- 8688 between 8:00AM and 5:00PM CST.
Quantity in Commerce 2
Distribution Worldwide Distribution - US Distribution to the states of : AZ, MO, PA and WI., and the countries of : Austria, India and Japan.
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.