FDA Device recall Z-1969-2023
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 (…
- FDA Device
- Class II
- ongoing
- Published 2023-06-21
On 2023-06-21 the FDA classified a Class II recall of 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 (… 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-1969-2023 |
| 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 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.
Identifiers
| code_info | REF/UDI-DI/LOT (Expiration): INT-028-27 (OEM)/22136556(2/28/2026); INT-105-25/00841268101845/23032145(12/28/2026), 2…REF/UDI-DI/LOT (Expiration): INT-028-27 (OEM)/22136556(2/28/2026); INT-105-25/00841268101845/23032145(12/28/2026), 22339238(10/03/2026), 22266856(8/25/2026), 23132602(4/04/2027), 23019935(12/13/2026), 22182660(6/13/2026); INT-106-09/00841268102156/23033942(12/28/2026), 22335239(10/03/2026), 22112754(3/14/2026), 21313293(11/11/2021), 21148681(5/03/2025), 22203491(7/07/2026), 21330748(10/27/2025), 21232023(8/02/2025), 22280971(8/30/2026); INT-106-12/00841268102187/23068151(2/21/2027); INT-106-17/00841268102231/23033947 (12/06/2026), 23167613(4/03/2027); DSS-007-04 (bulk)/PRCGM047382; DSS-007-05 (bulk)/PRCGM050270; DSS-010-065 (bulk)/PRCGM040042; DSS-012-07 (bulk)/PRCGM039532, PRCGM039096 |
|---|
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-1969-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.