Candela recalls 15-packs of surgical laser coolant canisters (Product #1600-00-0224) due to loose neck bushing that may separate during use in legacy devices with threaded DCD modules.
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-packs of surgical laser coolant canisters because the neck bushing may become loose and separate during use in specific legacy devices. This could cause the canister to detach, potentially leading to injury if the device is not properly secured.
The neck bushing can become loose and separate from the canister body during use. This issue occurs only when the canisters are used in legacy surgical devices with threaded interface DCD modules, which may lead to detachment and potential injury if the device is not securely anchored.
Surgical laser users who own the recalled canisters (Product #1600-00-0224) with legacy devices using threaded DCD modules are most at risk. The hazard affects only specific older models.
Check for the product number 1600-00-0224 (Revision .0C) on the canister label. The recall includes 15-packs sold with specific lot numbers listed in the record, including 1904CC1598 through 1908CC0025 and additional lots added after December 2019.
Look for the product number 1600-00-0224 (Revision .0C) on the canister label to confirm if it's recalled.
The neck bushing may become loose and separate from the canister body during use in legacy devices with threaded DCD modules, which could lead to detachment and potential injury.
No, the recall does not require immediate stop use. The hazard occurs only in specific legacy devices with threaded interfaces, so users should check their device compatibility before taking action.
The recall includes specific lot numbers from 1904CC1598 through 1908CC0025 and additional lots added after December 2019, as listed in the record.
We’ve drafted a message you can send Candela to request your refund or repair — edit it as you like.
Subject: Recall Z-0209-2020 — Candela Candela Hello, I own a Candela that is covered by recall Z-0209-2020 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.