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

Recall Z-2130-2019 — Thyroid Collar Oversize, Product Number TS3, Part Numbers RBTS3-R, RETS3-R, RLTS3-R, RLTS3-SEP, RLTS3-T2T Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of r

U.S. FDA — Device Enforcement · United States · 2019-06-07 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2130-2019
Date of alert: 2019-06-07
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Burlington Medical, LLC
Product category: device
Product type: Devices

Reported risk: The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.

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.

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