Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0207-2020 — Canister HFC-134a /1000g, ALUM, 15 pack Product Number: 1600-00-0219 Revision .0C Coolant canister for use with surgical laser.

U.S. FDA — Device Enforcement · United States · 2019-09-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0207-2020
Date of alert
2019-09-10
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Candela Corporation
Product category
device
Product type
Devices
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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