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

Recall Z-0687-2018 — Nitinol TC Reusable Electrodes (TCN), Model Numbers: 1)TCN-10, 2) TCNK-10-R, 3)TCN-10-3M, 4) TCNK-15, 5) TCN-15, 6) TCNK-15-C, 7) TCN-15-3M, 8) TCNK-15-R, 9) TCN-20, 10) TCNK-20, 11) TCN-20-3M, 12) TCNK-20-C, 13) TCN-5, 14) TCNK-20-R*, 15) TCN-5-3M, 16) TCNK-5, 17) TCNK-10, 18) TCNK-5-C, 19) TCN

U.S. FDA — Device Enforcement · United States · 2017-07-05 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →

Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0687-2018
Date of alert: 2017-07-05
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Cosman Medical, LLC
Product category: device
Product type: Devices

Reported risk: After multiple reprocessing cycles, the epoxy resin which holds the TCN Electrode in the hub can exhibit signs of damage. In some cases, this damage may result in the inability to fully remove blood and/or tissue residuals prior to cleaning and re-sterilizing the device.

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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Related