Candela HFC-134a Coolant Canisters Recalled Due to Loose Neck Bushing
Candela is recalling HFC-134a coolant canisters because the neck bushing may separate during use in specific legacy devices.
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 involves a medical device defect where a component may separate during use, posing a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Candela Corporation is recalling HFC-134a coolant canisters (Product Number 1600-00-0218, Revision .0C) used with surgical lasers. The recall involves 7,560 canisters in total, including 3,240 additional units added as of February 5, 2020.
The recall is due to a defect where 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 canisters were distributed to various states in the United States and to multiple international locations, including Canada, Germany, Spain, France, and Australia. Specific lot numbers are listed in the official recall notice. Users should stop using the affected canisters in the specified legacy devices and contact Candela Corporation for further instructions.
The recalled product
- Product
- Canister HFC-134a /1000g, ALUM Product Number: 1600-00-0218 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
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