Tearaway Introducer Set — Class II medical device recall Z-1969-2023
Ongoing recall by Galt Medical Corporation, reported 2023-06-21, distributed nationwide. Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer connection por
| Recall number | Z-1969-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Galt Medical Corporation, Garland, TX, United States |
| Recall initiated | 2023-05-08 |
| Classified | 2023-06-15 |
| Reported by FDA | 2023-06-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | GB |
| Quantity | 6,036 |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00841268101845, 00841268102156, 00841268102187, 00841268102231 |
| Lot numbers | DSS-007-04, DSS-007-05, DSS-010-065, DSS-012-07, INT-028-27, PRCGM039096 |
| Model numbers | DSS-007-04, DSS-007-05, DSS-010-065, DSS-012-07, INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1969-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.