Candela recalls 1000g HFC-134a coolant canisters for surgical lasers due to loose neck bushing that may separate during use in legacy devices.
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
Candela Corporation is recalling certain surgical laser coolant canisters because the neck bushing may become loose and separate during use in legacy devices with threaded interfaces. This could cause the canister to detach and potentially lead to injury if not properly secured.
The neck bushing inside the canister can become loose and separate from the canister body during use. This separation risk is specific to when the canisters are used in Candela's older devices that have threaded connections for DCD modules. If the bushing detaches, it could cause injury due to the canister moving unexpectedly.
Surgical laser users who own the recalled canisters with product number 1600-00-0218 revision .0C are most at risk. The hazard occurs only when these canisters are used in Candela legacy devices with threaded interface DCD modules.
Check for product number 1600-00-0218 revision .0C on the canister. The canisters were sold with specific lot numbers listed in the recall notice, including 1904CC1598 through 1908CC0025 and additional lots added after December 6, 2019.
Verify the product number and revision on the canister to confirm if it is recalled.
Reach out to Candela Corporation for specific guidance on handling the recalled canister.
The neck bushing may become loose and separate from the canister body during use in Candela legacy devices with threaded interface DCD modules.
The canister could detach unexpectedly, potentially causing injury if not properly secured.
Only Candela legacy devices that use screw-in or threaded interface type DCD modules.
We’ve drafted a message you can send Candela to request your refund or repair — edit it as you like.
Subject: Recall Z-0206-2020 — Candela Candela Hello, I own a Candela that is covered by recall Z-0206-2020 from Candela. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
