B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV
Summary
The FDA issued a Class II for B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 by Galt Medical Corporation. Reason: Due to a potential open seal in the sterile barrier packaging ..
Details
Source
Device Recall
External ID
Z-1733-2025
Action Date
2025-05-14
Status
Ongoing
Category
device
Product Description
B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV¿ Introducer System is indicated for use in percutaneous procedures to introduce catheters and other intravascular devices into the vasculature.
Lot/Code Info: Catalog Number: 612802 Model Number: BCL-100-04 Lot Number: S25128171
Quantity Affected: 100 systems
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-1733-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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