Recall Z-1732-2025 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
Galt Medical Corporation
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.
| 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 | 1,400 dilators |
| 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
| K000737 | COAXIAL DILATOR SET Xentek Medical, Inc., Aug 1, 2000 |