Canister HFC-134a /1000g, ALUM Product Number: 1600-00-0218 Revision .0C Coolant canister fo...

FDA Device Recall #Z-0206-2020 — Class II — September 10, 2019

Recall Summary

Recall Number Z-0206-2020
Classification Class II — Moderate risk
Date Initiated September 10, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Candela Corporation
Location Wayland, MA
Product Type Devices
Quantity in total 7,560 canisters (3240 additional as of 2/5/20)

Product Description

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

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

Distribution Pattern

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

Lot / 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

Other Recalls from Candela Corporation

Recall # Classification Product Date
Z-0207-2020 Class II Canister HFC-134a /1000g, ALUM, 15 pack Produc... Sep 10, 2019
Z-0208-2020 Class II Canister HFC-134a / 980g, ALUM Product Number:... Sep 10, 2019
Z-0209-2020 Class II Canister HFC-134a /980g, ALUM, 15 pack Product... Sep 10, 2019
Z-0348-2014 Class II Candela Laser GentleLase Pro, Powered Laser Sur... Nov 6, 2013

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.