FDA recall Z-0208-2020

Product

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

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2019-09-10

Report date

2019-10-30

Termination date

2020-10-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wayland, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0208-2020