FDA Device recall Z-1968-2023
Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16
- FDA Device
- Class II
- ongoing
- Published 2023-06-21
On 2023-06-21 the FDA classified a Class II recall of Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16 by Galt Medical, citing 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 re….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1968-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-08 |
| Published | 2023-06-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Galt Medical |
| Distribution | US |
Product
Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16
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.
Identifiers
| code_info | REF/UDI-DI/LOT (Expiration): KIT-010-12/00841268105195/S23104607(2/05/2027), S22356870(1/11/2027); KIT-010-17/00841268…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) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1968-2023%22
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