Reported May 14, 2025 · Ongoing
Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34, 00841268104792 KIT-002-35, 00841268104808…
Galt Medical Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Galt Medical Corporation · 2220 Merritt Dr · Garland, TX · 75041-6137
Is this the product you have?
- Introducer Kit- Coaxial Dilator REFKIT-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
- Lot codes and dates
9 of 9 products
Products covered by this recall # Barcodes Product as published 1 00841268104792Lot Number: G25038156 KIT-002-34, UDI-DI code: 00841268104792 2 00841268104808Lot Number: G25064259 KIT-002-35, UDI-DI code: 00841268104808 3 00841268105553Lot Number: G25029077 KIT-011-40, UDI-DI code: 00841268105553 4 00841268105614Lot Number: S25031227 KIT-011-62, UDI-DI code: 00841268105614 5 00841268104556Lot Numbers: G25052163 G25080165 KIT-038-04, UDI-DI code: 00841268104556 6 00841268104587Lot Number: G25092186 KIT-039-03, UDI-DI code: 00841268104587 7 00841268106055Lot Numbers: G25050190 G25078192 KIT-039-13, UDI-DI code: 00841268106055 8 00841268108394Lot Number: G25050202 KIT-081-02 / PS2-38, UDI-DI code: 00841268108394 9 Lot Number: G25056231 - Amount recalled
- 4,280 kits
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
Due to a potential open seal in the sterile barrier packaging.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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