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

Recall Z-2565-2018 — Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-50; d) DSS-005-11; e) DSS-005-12; f) DSS-006-045; g) DSS-007-05; h) DSS-007-165; i) DSS-010-03; j) DSS-010-04; k) DSS-010-045; l) DSS-010-05; m) DSS-012-07; n) SPT-003-46

U.S. FDA — Device Enforcement · United States · 2018-05-02 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2565-2018
Date of alert
2018-05-02
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Galt Medical Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
18024880
Reported risk: The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.
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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