Med Tec Inc recalls Type S Extension For use with Varian, CIVCO, Prescription Only - Product Usage: Device is intended for patient position…

Recall date

May 12, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2243-2020

FDA classification

Class II

Brand / firm

Med Tec Inc

Sold / distributed

Worldwide distribution - US Nationwide distribution including in the states of WI, TX, AZ, FL, NE, TN, MA, FL, GA, IN, OR, PA, IL, LA, NH, MS, MI, OH, MN, VA, IA, CA, NC, SC, AK, UT, WA, MO, MT, KS, and WV. The countries of Africa, Colombia, Saudi Arabia, Costa Rica, South Korea, Hungary, Spain, an…

Why it was recalled

Potential for disengagement of the Varian Style Type-S Extension during patient repositioning. The risk associated with the disengagement of the extension could be a patient fall if the patient is not supported by clinical staff.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Type S Extension For use with Varian, CIVCO, Prescription Only - Product Usage: Device is intended for patient positioning.