FDASeptember 10, 2019device
Canister HFC-134a /980g, ALUM, 15 pack Product Number: 1600-00-0224 Revision .0C Coolant canister for use with surgical laser.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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
What to do
FDA enforcement status: Terminated
Brands named
candela
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDACanister HFC-134a / 980g, ALUM Product Number: 1600-00-0223 Revision .0C Coolant canister for use with surgical laser.2019-09-10
- FDACanister HFC-134a /1000g, ALUM, 15 pack Product Number: 1600-00-0219 Revision .0C Coolant canister for use with surgical laser.2019-09-10
- FDACanister HFC-134a /1000g, ALUM Product Number: 1600-00-0218 Revision .0C Coolant canister for use with surgical laser.2019-09-10
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