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

Recall Z-1969-2023 — Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17, DSS-007-04, DSS-007-05, DSS-010-065, DSS-012-07 (bulk)

U.S. FDA — Device Enforcement · United States · 2023-05-08 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1969-2023
Date of alert: 2023-05-08
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Galt Medical Corporation
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 22136556

Reported risk: Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer connection portion of the dilator hub that cracks or dislodges during use, which renders the dilator component unusable, and can require the use of a replacement 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.

Recall Z-1969-2023 — Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17, DSS-007-04, DSS-007-05, DSS-010-065, DSS-012-07 (bulk)

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