B Braun Elite HV Hemostasis Valve (Galt Medical) – Sterile Packaging Seal (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Galt Medical Corporation
Lot Codes / Batch Numbers
Catalog Number: 612802 Model Number: BCL-100-04 Lot Number: S25128171
Products Sold
Catalog Number: 612802 Model Number: BCL-100-04 Lot Number: S25128171
Galt Medical Corporation is recalling B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100- due to Due to a potential open seal in the sterile barrier packaging .. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to a potential open seal in the sterile barrier packaging .
Recommended Action
Per FDA guidance
On 03/27/2025, the firm emailed customers an "URGENT: MEDICAL DEVICE RECALL" Letter informing them that affected products may have an open seal in the sterile barrier packaging that will render the product non-sterile and will increase the risk of patient harm due to microbial and environmental contamination. Customers are instructed to: 1.DO NOT USE OR DISTRIBUTE THE DEVICEs LISTED IN THIS RECALL. Identify and segregate the affected lot(s) that are in their possession as well as those in the possession of their end-users. 2. Complete the enclosed Field Correction Reply Forms and email or fax them to the attention of the Corrections Coordinator at quality@galtmedical.com or 214-778-1433. We have enclosed two forms: one to account for inventory at their facility and the other for capturing these exact details from their end users. The form lists the product number, lot number, and quantity that the firm's records indicate their facility has received. It is essential that, even if they do not have any product remaining in their possession, they complete the attached forms (Attachment A & B), indicating zero quantity to be returned, and email or fax the forms to GALT MEDICAL CORP. 3. Ship the returned product to GALT MEDICAL CORP. using Galt s carrier account information listed on the forms. 4. Reference Return Authorization Number RMA# 1200 on the outside of the shipping box and include a copy of the Field Correction Reply Forms with their shipment. 5. Once the completed Field Correction Reply Forms have been received and processed, Galt will issue a credit to customers for the returned product. Please place a new purchase order (PO), noting Replacement Parts for new products. For questions, contact Quality Director at 1-214-778-1306
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026