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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Hazard
Distribution
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 →Related recalls
Same manufacturer · Candela Corporation
See all →- HighCandela Surgical Laser Coolant Canisters Recalled for Loose Bushing
FDA (Devices) · 2019-10-30
- HighCandela HFC-134a Coolant Canisters Recalled Due to Loose Neck Bushing
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- HighCandela HFC-134a Coolant Canisters Recalled for Loose Neck Bushing
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