Recall Z-2763-2015 ยท FMQ Restraint, Protective
Med Tec Inc
CIVCO Shoulder Retractors, Reusable non-sterile hand grip, REF 302070, packaged 1 set per box, RX. For use in patient positioning. The grips are used for pulling down the shoulders during radiotherapy simulation and treatment sessions where opposed lateral fields are used in the neck area.
| Date | Sep 14, 2015 (initiated Aug 19, 2015) |
| Status | Terminated |
| Reason | The wrist straps used for positioning the patient are too long |
| Root cause | Vendor change control |
| Action | 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. |
| Quantity | 18 sets |
| Distribution | Worldwide Distribution - US including NE, SC, and KS. Foreign distribution was made to Australia, China, Venezuela, Spain, Turkey, and Hong Kong |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.