Candela Corporation recalls Canister HFC-134a / 980g, ALUM Product Number: 1600-00-0223 Revision .0C Coolant canister for use with surgical laser.

Recall date

September 10, 2019

Source

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

Recall number

Z-0208-2020

FDA classification

Class II

Brand / firm

Candela Corporation

Sold / distributed

States: NC GA CA MA OH FL IL CO SD NY KS WA MI PA AZ WI TX LA IA MN VA TN SC OR IN WY MD VT ON BC QC NV OUS: Barbados Canada Germany Spain France HR Portugal Ireland Norway Greece NL South Africa Vietnam Hong Kong Japan New Zealand Australia China Korea

Why it was recalled

The canister neck bushing may become loose and separate from the body of the canister during use. The issue occurs only when the canisters are used in Candela legacy devices that utilize screw-in or threaded interface type DCD modules

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

What was recalled

Canister HFC-134a / 980g, ALUM Product Number: 1600-00-0223 Revision .0C Coolant canister for use with surgical laser.