Recall Z-2763-2015— Med Tec Inc
Class II · Terminated
Class II FDA medical device recall by Med Tec Inc, initiated 2015-08-19, terminated 2016-10-07. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: The wrist straps used for positioning the patient are too long.
- Recalling firm
- Med Tec Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-08-19
- Terminated
- 2016-10-07
- Firm location
- Orange City, IA, United States
Product description
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.
Reason for recall
The wrist straps used for positioning the patient are too long
Data sourced from openFDA. This site is unofficial and independent of the FDA.