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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1968-2023 |
| Event ID | 92322 |
| Event Description | Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16 |
| Product Type | Devices |
| Distribution | 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. |
| Quantity | 490 |
| Recall 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. |
| Device Classification | 20230621 |
| Device Code Info | 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) |
| Center Classification Date | 20230615 |
| Recall Initiation Date | 20230508 |
| Recalling Firm | Galt Medical Corporation |
| Initial Notification | Letter |
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