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Candela Corporation recalls Canister HFC-134a /1000g, ALUM, 15 pack Product Number: 1600-00-0219 Revision .0C Coolant canister for use with sur
Recalled October 30, 2019 · FDA recall Z-0207-2020 · Candela
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 · FDA Class II
Units
386 cases ( 15 pack canister/ case) (216 additional cases as of 12/09/19)
Sold at
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Description
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
Product
Canister HFC-134a /1000g, ALUM, 15 pack Product Number: 1600-00-0219 Revision .0C Coolant canister for use with surgical laser.
Manufacturer(s)
Candela Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →