FDA-Device2015-01-21Class II
Civco, MTSR02 Shoulder Retractor with Sherpa Wrist Loops Kit with Base, Non-sterile re-usable wool wrist strap, REF: 20SR02SUB2, Rx Only, The devise is intended to pull patients shoulders down for clearance when treating lateral fields to the neck.
Med Tec Inc
Hazard
The product (wool wrist loop) was manufactured 7cm shorter than product specifications.
Sold states
Worldwide Distribution - US Distribution to the states of : AZ, MO, PA and WI., and the countries of : Austria, India and Japan.
Affected count
11
Manufactured in
1401 8th St SE, PO Box 320, Orange City, IA, United States
Products
Civco, MTSR02 Shoulder Retractor with Sherpa Wrist Loops Kit with Base, Non-sterile re-usable wool wrist strap, REF: 20SR02SUB2, Rx Only, The devise is intended to pull patients shoulders down for clearance when treating lateral fields to the neck.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0989-2015Don't want to check this manually?
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