Reported May 14, 2025 · Ongoing
B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introducer Kits…
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?
- B Braun
- Interventional Coaxial Dilator REFKIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the vascular system following a small gauge needle stick
- Lot codes and dates
4 of 4 products
Products covered by this recall # Barcodes Product as published 1 0404696432738Lot Number: S25052261 KIT-019-67 UDI-DI code: 0404696432738 2 0404696432750Lot Number: P25052052 KIT-018-41 UDI-DI code: 0404696432750 3 0404696432802Lot Number: S25064124 KIT-019-37 UDI-DI code: 0404696432802 4 Lot Number: P25115062 - Amount recalled
- 1,400 dilators
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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new packaged foods recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.