Recall Z-2565-2018— Galt Medical Corporation

Name: FDA recall Z-2565-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-02

Class II · Terminated

Class II FDA medical device recall by Galt Medical Corporation, initiated 2018-05-02, terminated 2020-07-20. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: 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..

Recalling firm: Galt Medical Corporation
Classification: Class II
Status: Terminated
Initiated: 2018-05-02
Terminated: 2020-07-20
Firm location: Garland, TX, United States

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.