Class 2 Device Recall GentleCool Pro DCD

• Date Initiated by Firm: September 10, 2019
• Date Posted: October 24, 2019
• Recall Status: Terminated on October 20, 2020
• Recall Number: Z-0206-2020
• Recall Event ID: 83839
• Product Classification: Powered laser surgical instrument - Product Code GEX
• Product: Canister HFC-134a /1000g, ALUM Product Number: 1600-00-0218 Revision .0C Coolant canister for use with surgical laser.
• Code Information: 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
• FEI Number: 1218402
• Recalling Firm/ Manufacturer: Candela Corporation; 530 Boston Post Rd; Wayland MA 01778-1833
• For Additional Information Contact: Sharon Timberlake; 508-358-7400
• Manufacturer 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 Determined 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 cryogen.usa@candelamedical.com 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 cryogen.usa@candelamedical.com. 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.