Z-0208-2020Class II

Canister HFC-134a / 980g, ALUM Product Number: 1600-00-0223 Revision .0C Coolant canister for use with...

Name: Z-0208-2020 Canister HFC-134a / 980g, ALUM Product Number: 1600-00-0223 Revision .0C Coolant canister for use with...
Creator: Candela Corporation
Published: 2019-09-10
License: https://open.fda.gov/license/

Candela Corporation / initiated 2019-09-10 / Terminated

FDA source

Candela Corporation began a recall of Canister HFC-134a / 980g, ALUM Product Number: 1600-00-0223 Revision .0C Coolant canister for use with surgical laser on 2019-09-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0208-2020
Classification: Class II
Status: Terminated
Initiated: 2019-09-10
Posted: 2019-10-24
Terminated: 2020-10-20
Recalling firm: Candela Corporation
Product: Canister HFC-134a / 980g, ALUM Product Number: 1600-00-0223 Revision .0C Coolant canister for use with surgical laser.
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: 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 root cause: Other
Action: 1. Immediately examine your inventory and quarantine the identified lots of the GentleCool Pro Cryogen Canister. 2. Immediately discontinue use and distribution of the identified lots of the GentleCool Pro Cryogen Canister. 3. Please complete and return the enclosed Acknowledgement Form - GentleCool Pro Canister Recall. The completed form must be scanned and emailed to [email protected] within 24 hours. 4. If you may have further distributed this product, please identify those locations and notify them at once of this product recall. Your communication should include a copy of this recall notification letter. 5. Please contact Candela Customer Service at 800-733-8550 ext. 0 to make arrangements for replacement of your affected inventory. 6. Information regarding retrieval of your affected inventory will be forthcoming from Candela Medical. If you have any questions, please do not hesitate to call our Customer Service team at 800-733-8550 ext. 0, M-F 8:30 am 8 pm EST, or reach them via email at [email protected]. An Urgent Medical Device Expanded Recall notification letter dated 12/6/19 was sent to customers. Twenty additional lots have now been identified (listed in bold on the following page), since the initial notification was sent mid-September. Thus, we are updating this notice to make you aware of these additional lots. The reason for this expanded recall is unchanged from the initial communications sent. Actions to Be Taken by the Customer/User: To safely and efficiently implement this recall, we are asking that you please take the following actions: 1. Immediately examine your inventory and quarantine the identified lots of the GentleCool Pro Cryogen Canister. 2. Immediately discontinue use and distribution of the identified lots of the GentleCool Pro Cryogen Canister. 3. Please complete and return the enclosed Acknowledgement Form - GentleCool Pro Canister Recall. The completed form must be sca
Quantity in commerce: in total 7,560 canisters (3240 additional as of 2/5/20)
Distribution: States: NC GA CA MA OH FL IL CO SD NY KS WA MI PA AZ WI TX LA IA MN VA TN SC OR IN WY MD VT ON BC QC NV OUS: Barbados Canada Germany Spain France HR Portugal Ireland Norway Greece NL South Africa Vietnam Hong Kong Japan New Zealand Australia China Korea
Product codes and lots: Lot # 1904CC1598 1905CC0007 1905CC0178 1905CC0217 1906CC0196 1906CC0172 1907CC0008 1908CC0025 Additional lots added as of 12/6/2019: 1902CC0043 1902CC0143 1811CC0016 1812CC0074 1812CC0133 1901CC0087 1904CC0126 1802CC0092 1802CC0232 1803CC0169 1804CC0073 1805CC0058 1806CC0068 1807CC0009 1807CC0104 1808CC0112 1809CC0070 1810CC0015 1810CC0117 1907CC0187

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0208-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0206-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-30	2019-10-24
Z-0207-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-30	2019-10-24
Z-0208-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-30	2019-10-24
Z-0209-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-30	2019-10-24

Product code GEX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)