Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34, 00841268104792 KI...
FDA Device Recall #Z-1735-2025 — Class II — March 27, 2025
Recall Summary
| Recall Number | Z-1735-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 27, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Galt Medical Corporation |
| Location | Garland, TX |
| Product Type | Devices |
| Quantity | 4,280 kits |
Product Description
Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34, 00841268104792 KIT-002-35, 00841268104808 KIT-011-40, 00841268105553 KIT-011-62, 00841268105614 KIT-038-04, 00841268104556 KIT-039-03, 00841268104587 KIT-039-13, 00841268106055 KIT-081-02 / PS2-38, 00841268108394 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the peripheral vascular system following a small gauge needle stick.
Reason for Recall
Due to a potential open seal in the sterile barrier packaging.
Distribution Pattern
Worldwide - U.S. Nationwide distribution in the states of AL, FL, GA, IL, MA, OH, PA, and UT. The countries of Canada, Ireland, Israel, Korea, Qatar, and United Kingdom.
Lot / Code Information
Catalog Number: KIT-002-28 UDI-DI code: 00841268104730 Lot Number: G25038156 KIT-002-34, UDI-DI code: 00841268104792 Lot Number: G25064259 KIT-002-35, UDI-DI code: 00841268104808 Lot Number: G25029077 KIT-011-40, UDI-DI code: 00841268105553 Lot Number: S25031227 KIT-011-62, UDI-DI code: 00841268105614 Lot Numbers: G25052163 G25080165 KIT-038-04, UDI-DI code: 00841268104556 Lot Number: G25092186 KIT-039-03, UDI-DI code: 00841268104587 Lot Numbers: G25050190 G25078192 KIT-039-13, UDI-DI code: 00841268106055 Lot Number: G25050202 KIT-081-02 / PS2-38, UDI-DI code: 00841268108394 Lot Number: G25056231
Other Recalls from Galt Medical Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1732-2025 | Class II | B Braun Interventional Coaxial Dilator REF: K... | Mar 27, 2025 |
| Z-1733-2025 | Class II | B Braun Interventional ELITE HV Hemostasis Valv... | Mar 27, 2025 |
| Z-1731-2025 | Class II | GALT Centeze Catheter REF: DRC-002-05 DRC-00... | Mar 27, 2025 |
| Z-1736-2025 | Class II | Introducer Needle REF NDL-107-04 These need... | Mar 27, 2025 |
| Z-1734-2025 | Class II | GALT Guidewire REF SGW-051-07 Guidewires ar... | Mar 27, 2025 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.