medical Class II Updated 2019-10-30

Candela Corporation recalls Canister HFC-134a /1000g, ALUM Product Number: 1600-00-0218

Recalled Product

Canister HFC-134a /1000g, ALUM Product Number: 1600-00-0218 Revision .0C Coolant canister for use with surgical laser.

Hazard / Issue

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

Issued by

FDA

Affected 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, NV

Lot/Code Info: 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

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