Med Tec Inc recalls CIVCO Arm Support, REF 106015, distributed as: (a) Rigid Arm Support, Standard, Set Red (PN: 106015) (b) Rigid Adj. Arm…

Recall date

August 10, 2017

Source

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

Recall number

Z-3082-2017

FDA classification

Class II

Brand / firm

Med Tec Inc

Sold / distributed

Worldwide Distribution - US Distribution to the states of : MI, IL and TX., and to the countries of : Greece, Australia, Czech Republic, Hungary, Norway, Brazil, Italy, Switzerland ,UK, Austria, Slovenia, Croatia, Poland, Germany, Japan, France, Netherland, Sri Lanka, Pakistan, Bangladesh, and Isra…

Why it was recalled

Rigid Arm Supports (PN: 106015 and 106047), which were used as part of the Posiboard-2 and Posirest, and were distributed as PN: 106015, 106047, 106521, 106522, 109030, and 109040 between Ocotober 2009 and July 2012 may have a height difference of approximately 17mm.

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

What was recalled

CIVCO Arm Support, REF 106015, distributed as: (a) Rigid Arm Support, Standard, Set Red (PN: 106015) (b) Rigid Adj. Arm Support, Set (PN: 106020) (c) PSR2-CR-DLR-2P Posirest-2 (PN: 106521) (d) PB2-BLR Posiboard-2 (PN: 109030) The Rigid Arm Supports are utilized on the Posibboard2 and Posirest assemblies, which are intended to position the patients upper extremities during breast and lung diagnostic and radiotherapy treatment..