The Recall Desk
HighFDA (Devices)·Z-0208-2020·Announced 2019-10-30

Candela HFC-134a Coolant Canisters Recalled for Loose Neck Bushing

Candela Corporation is recalling HFC-134a coolant canisters because the neck bushing may become loose and separate from the canister body during use.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a component separating during use of a surgical laser, which poses a risk of harm even though specific injuries are not reported in the source text.

Plain-English summary

Candela Corporation is recalling 7,560 HFC-134a coolant canisters (Product Number 1600-00-0223, Revision .0C) used with surgical lasers. The recall includes 3,240 additional canisters added as of February 5, 2020. The affected lots are 1904CC1598, 1905CC0007, 1905CC0178, 1905CC0217, 1906CC0196, 1906CC0172, 1907CC0008, 1908CC0025, and additional lots added as of December 6, 2019: 1902CC0043, 1902CC0143, 1811CC0016, 1812CC0074, 1812CC0133, 1901CC0087, 1904CC0126, 1802CC0092, 1802CC0232, 1803CC0169, 1804CC0073, 1805CC0058, 1806CC0068, 1807CC0009, 1807CC0104, 1808CC0112, 1809CC0070, 1810CC0015, 1810CC0117, and 1907CC0187.

The recall is due to a defect where the canister neck bushing may become loose and separate from the body of the canister during use. This issue occurs only when the canisters are used in Candela legacy devices that utilize screw-in or threaded interface type DCD modules.

The canisters were distributed to 26 U.S. states and multiple international locations, including Canada, Germany, Spain, France, and Australia. Healthcare providers and facilities using these specific canisters with Candela legacy devices should stop using the affected units and contact Candela Corporation for instructions on return or replacement.

The recalled product

Product
Canister HFC-134a / 980g, ALUM Product Number: 1600-00-0223 Revision .0C Coolant canister for use with surgical laser.
Manufacturer
Candela Corporation
Category
Medical Device — Surgical Laser Accessories
Hazard

Distribution

Distributed in 28 states:

Part of a larger recall action

This product is one of 4 recalled by Candela Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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