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

Recall Z-1781-2021 — Tranberg MR Stylet, 1.8mm/15G, 230mm, REF: 4013-06, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue.

U.S. FDA — Device Enforcement · Sweden · 2021-04-01 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1781-2021
Date of alert: 2021-04-01
Country / jurisdiction: Sweden
Risk level: Class II
Risk type: recall
Brand: CLINICAL LASERTHERMIA SYSTEMS AB
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 116540030718

Reported risk: single use devices labeled as sterile may not have been adequately sterilized

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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.

Recall Z-1781-2021 — Tranberg MR Stylet, 1.8mm/15G, 230mm, REF: 4013-06, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue.

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