Z-1733-2025Class II

B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The...

Name: Z-1733-2025 B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The...
Creator: Galt Medical Corporation
Published: 2025-03-27
License: https://open.fda.gov/license/

Galt Medical Corp / initiated 2025-03-27 / Open, Classified / root cause: manufacturing process

FDA source

Galt Medical Corporation began a recall of 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... on 2025-03-27. FDA classified it as Class II and gives the reason as "Due to a potential open seal in the sterile barrier packaging". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1733-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-27
Posted: 2025-05-07
Recalling firm: Galt Medical Corp
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.
Product code: DYB Introducer, Catheter
Reason for recall: Due to a potential open seal in the sterile barrier packaging .
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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 [email protected] 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
Quantity in commerce: 100 systems
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.
Product codes and lots: Catalog Number: 612802 Model Number: BCL-100-04 Lot Number: S25128171

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1733-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1731-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-14	2025-05-07
Z-1732-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-14	2025-05-07
Z-1733-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-14	2025-05-07
Z-1734-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-14	2025-05-07
Z-1735-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-14	2025-05-07
Z-1736-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-14	2025-05-07
Z-1737-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-14	2025-05-07

Product code DYB

K043525Class IICatheter IntroducerGalt Medical Corp. / cleared 2005-02-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)