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.
Recall
- Recall Number
- Z-0990-2015
- Event Number
- 69997
- Firm
- Med Tec Inc
- FEI Number
- 1000143606
- Product Code
- FMQ
- Status
- Terminated
- Root Cause
- Component design/selection
- Initiated
- December 11, 2014
- Posted
- January 15, 2015
- Terminated
- February 3, 2017
- Address
- 1401 8th St SE PO Box 320, Orange City, IA, 51041-7463
Description
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.
The product (wool wrist loop) was manufactured 7cm shorter than product specifications.
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.
Worldwide Distribution - US Distribution to the states of : AZ, MO, PA and WI., and the countries of : Austria, India and Japan.
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