Reported Oct 30, 2019 · Terminated
Canister HFC-134a /1000g, ALUM Product Number: 1600-00-0218 Revision .0C Coolant canister for use with surgical laser.
Candela Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Candela Corporation · 530 Boston Post Rd · Wayland, MA · 01778-1833
Is this the product you have?
- Canister HFC-134a /1000g
- ALUM Product Number1600-00-0218 Revision .0C Coolant canister for use with surgical laser
- Lot codes and dates
- Lot #
1904CC15981905CC00071905CC01781905CC02171906CC01961906CC01721907CC00081908CC0025
- Additional lots added as of 12/6/2019
1902CC00431902CC01431811CC00161812CC00741812CC01331901CC00871904CC01261802CC00921802CC02321803CC01691804CC00731805CC00581806CC00681807CC00091807CC01041808CC01121809CC00701810CC00151810CC01171907CC0187
- Lot #
- Amount recalled
- in total 7,560 canisters (3240 additional as of 2/5/20)
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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