Recall Z-1969-2023— Galt Medical Corporation

Name: FDA recall Z-1969-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-08

Class II · Ongoing

Class II FDA medical device recall by Galt Medical Corporation, initiated 2023-05-08. It names one FDA 510(k) clearance: K153533. Product: 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). Reason: 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..

Recalling firm: Galt Medical Corporation
Classification: Class II
Status: Ongoing
Initiated: 2023-05-08
Firm location: Garland, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K153533 — Tearaway Introducer Sheath, MicroSlide Tearaway IntroducerGalt Medical Corp.·cleared 2016-07-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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)

Reason for recall

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.

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