Candela recalls 15-pack HFC-134a coolant canisters for potential neck bushing separation in legacy surgical laser 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 15-pack HFC-134a coolant canisters that may have a loose neck bushing which could separate during use in specific legacy surgical laser devices. This could cause the canister to become dislodged and potentially lead to injury if the device is not properly secured.
The neck bushing in these canisters may become loose and separate from the canister body during use. This separation can happen only when the canisters are used in specific legacy surgical laser devices that have screw-in or threaded interface DCD modules. If the bushing separates, the canister could become dislodged and potentially cause injury.
Surgical laser users who own the specific 15-pack canisters with product number 1600-00-0219 revision .0C are most at risk. The hazard occurs only when these canisters are used in Candela's legacy devices with screw-in or threaded interface DCD modules.
Check for the product number 1600-00-0219 revision .0C on the canister label. The 15-pack canisters were sold with specific lot numbers including 1904CC1598 through 1908CC0025 and additional lots added after December 9, 2019.
Look for product number 1600-00-0219 revision .0C on the canister label to confirm if it's affected.
If you have the affected canisters, use them only in Candela legacy devices with screw-in or threaded interface DCD modules, and ensure they are properly secured.
The neck bushing in these canisters may become loose and separate from the canister body during use in specific legacy surgical laser devices, which could lead to injury if the canister becomes dislodged.
Check the canister label for product number 1600-00-0219 revision .0C. If affected, use them only in Candela legacy devices with screw-in or threaded interface DCD modules and ensure they are properly secured.
Yes, the affected canisters include specific lot numbers from 1904CC1598 through 1908CC0025 and additional lots added after December 9, 2019.
We’ve drafted a message you can send Candela to request your refund or repair — edit it as you like.
Subject: Recall Z-0207-2020 — Candela Candela Hello, I own a Candela that is covered by recall Z-0207-2020 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.
