Candela HFC-134a Coolant Canisters Recalled for Loose Neck Bushing
Candela Corporation is recalling HFC-134a coolant canisters because the neck bushing may become loose and separate from the canister body during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a component separating during use of a surgical device, which poses a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
Candela Corporation is recalling specific lots of HFC-134a coolant canisters (Product Number: 1600-00-0219, Revision .0C). These canisters are used with surgical lasers. The recall involves 386 cases, with an additional 216 cases added as of December 9, 2019.
The recall was initiated because the canister neck bushing may become loose and separate from the body of the canister during use. This issue occurs only when the canisters are used in Candela legacy devices that utilize screw-in or threaded interface type DCD modules.
The affected products were distributed in numerous US states and internationally, including Canada, Germany, Spain, France, and Australia. Users should stop using the affected canisters and contact Candela Corporation for further instructions.
The recalled product
- Product
- Canister HFC-134a /1000g, ALUM, 15 pack Product Number: 1600-00-0219 Revision .0C Coolant canister for use with surgical laser.
- Manufacturer
- Candela Corporation
- Hazard
Distribution
Part of a larger recall action
This product is one of 4 recalled by Candela Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Candela Corporation
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