Civco, MTSR03 Shoulder Retractor with Wrist Loops Kit with Base, plus two pairs of wrist loops (nylon and sherpa), Non-s

FDA device recall Z-0990-2015 · posted 2015-01-15 · Terminated

Recall details

Recalling firm

Med Tec Inc

Reason for recall

The product (wool wrist loop) was manufactured 7cm shorter than product specifications.

Action taken

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.

Root cause

Component design/selection

Status

Terminated

Product code

FMQ

Quantity affected

2

Distribution

Worldwide Distribution - US Distribution to the states of : AZ, MO, PA and WI., and the countries of : Austria, India and Japan.

Date initiated

2014-12-11

Date posted

2015-01-15

Date terminated

2017-02-03

Location

Orange City, IA