Z-0206-2020 Class II Terminated
FDA device recall Z-0206-2020 was initiated by Candela Corporation on September 10, 2019 and is designated Class II. 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… The recall status is terminated (terminated October 20, 2020). Affected quantity: in total 7,560 canisters (3240 additional as of 2/5/20).
Recall Details
- Product Type
- Devices
- Report Date
- October 30, 2019
- Initiation Date
- September 10, 2019
- Termination Date
- October 20, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- in total 7,560 canisters (3240 additional as of 2/5/20)
Product Description
Reason for Recall
Distribution Pattern
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