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Recall Observatory FDA recall evidence

Device product

Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16

Z-1968-2023

May 08, 2023

Class II

Product summary

Firm
Galt Medical Corporation
Event
Event 92322
Status
Ongoing
Classification
Class II
Quantity
490
Official record key
device-enforcement:Z-1968-2023

Official wording

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.

Code information: REF/UDI-DI/LOT (Expiration): KIT-010-12/00841268105195/S23104607(2/05/2027), S22356870(1/11/2027); KIT-010-17/00841268105249/S23083725(2/05/2027), S22231321(9/08/2026), S22328872(1/18/2027); KIT-900-16/S22308637(1/04/2027)

Distribution pattern: Worldwide - US Nationwide distribution in the states of PA, UT, FL, PA, OH, GA, MA, NV, CA, NY, NJ and the countries of UK, AU, TR, FR, CH, NO.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.