GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE… — Class II medical device recall Z-2588-2014
Terminated recall by Galt Medical Corporation, reported 2014-09-10, distributed nationwide. The adhesive used in the product could dislodge when objects are inserted through the valve which could pose a
| Recall number | Z-2588-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Galt Medical Corporation, Garland, TX, United States |
| Recall initiated | 2014-07-25 |
| Classified | 2014-09-04 |
| Reported by FDA | 2014-09-10 |
| Terminated | 2016-02-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CH, DE, FR, GR, IE, IT, NL |
| Quantity | 11,155 units |
| Model numbers | INT-104-07, INT-104-08, INT-104-09, INT-104-10, INT-104-11, INT-104-12, INT-104-17, INT-104-18, INT-104-19, INT-104-20, INT-104-21, INT-104-22, INT-104-23, INT-108-06, INT-108-07, INT-108-09, INT-108-10, INT-108-11, INT-108-12, INT-108-17, INT-108-18, INT-108-19, INT-108-20, INT-108-21, INT-108-22 and 29 more |
Product
GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.
Reason for recall
The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient.
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-2588-2014. 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.