FDAFDA · Food and drugs·Recall number Z-0989-2015
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.
Published January 21, 2015 · Recall initiated: December 11, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The product (wool wrist loop) was manufactured 7cm shorter than product specifications.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Med Tec Inc
- Distributor
- Worldwide Distribution - US Distribution to the states of : AZ, MO, PA and WI., and the countries of : Austria, India and Japan.
- Lot
- Lot: M612690 REF: 20SR02SUB2
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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