B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introduce
Summary
The FDA issued a Class II for B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018- by Galt Medical Corporation. Reason: Due to a potential open seal in the sterile barrier packaging ..
Details
Source
Device Recall
External ID
Z-1732-2025
Action Date
2025-05-14
Status
Ongoing
Category
device
Product Description
B Braun Interventional Coaxial Dilator REF: KIT-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/Code Info: KIT-018-47 UDI-DI code: 0404696432727 Lot Number: S25052261 KIT-019-67 UDI-DI code: 0404696432738 Lot Number: P25052052 KIT-018-41 UDI-DI code: 0404696432750 Lot Number: S25064124 KIT-019-37 UDI-DI code: 0404696432802 Lot Number: P25115062
Quantity Affected: 1,400 dilators
Reason for Recall
Due to a potential open seal in the sterile barrier packaging .
Distribution
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-03-27
Company
Garland, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 146 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Galt Medical Corporation has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Galt Medical Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Galt Medical Corporation have FDA actions?
Galt Medical Corporation has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1732-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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