CIVCO Shoulder Retractors, Reusable non-sterile hand grip, REF 302070, packaged 1 set per box, RX. For use in patient po

FDA device recall Z-2763-2015 · posted 2015-09-14 · Terminated

Recall details

Recalling firm

Med Tec Inc

Reason for recall

The wrist straps used for positioning the patient are too long

Action taken

Med Tec Inc sent an Urgent Field Correction Notice dated August 18, 2015, via e-mail on August 19, 2015, and made phone calls on August 19, 2015, to all affected customers requesting return of the product. Customers were instructed to forward a copy of the notification letter to all customers who have received the product. Customers with questions were instructed to reach their representative by calling CIVCO Medical Solutions, adiation Oncology, at 800-842-8688 or 319-248-8688 between 8:00AM and 5:00PM CST. For questions regarding this recall call319-248-6502.

Root cause

Vendor change control

Status

Terminated

Product code

FMQ

Quantity affected

18 sets

Distribution

Worldwide Distribution - US including NE, SC, and KS. Foreign distribution was made to Australia, China, Venezuela, Spain, Turkey, and Hong Kong

Date initiated

2015-08-19

Date posted

2015-09-14

Date terminated

2016-10-07

Location

Orange City, IA