Product Safety Recalls

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Galt Medical Corporation Recall 92322

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

Galt Medical Corporation Recall 92322 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1968-2023
Event ID92322
Event DescriptionTearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16
Product TypeDevices
DistributionWorldwide - 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.
Recall ReasonSheath 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.
Device Classification20230621
Device Code InfoREF/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)
Center Classification Date20230615
Recall Initiation Date20230508
Recalling FirmGalt Medical Corporation
Initial Notification Letter
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