Recall Z-1733-2025 ยท DYB Introducer, Catheter
Galt Medical Corporation
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.
| Date | May 7, 2025 (initiated Mar 27, 2025) |
| Status | Open, Classified |
| Reason | Due to a potential open seal in the sterile barrier packaging . |
| 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043525 | CATHETER INTRODUCER Galt Medical Corp., Feb 9, 2005 |