Recall Z-1592-2010 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
Galt Medical Corp
Micro Introducer Kit 5F, Model number: KIT-014-29, & Customer Model number: 7204. Vascular Solutions, 6464 Sycamore Court, Minneapolis, MN 53369.
| Date | May 11, 2010 (initiated Feb 8, 2010) |
| Status | Terminated |
| Reason | Potential problem with pouch seal thus affecting sterile product. |
| Root cause | Packaging process control |
| Action | Firm notified distributor by telephone 2/8/2010. Firm and distributor partnered to notify customers by an Urgent: Medical Device Recall - Lot Specific letter, dated 2/10/2010, beginning 2/16/2010. The letter identified the affected product and the reason for the recall. The letter asked customers to immediately check their inventory remove any affected kits and place them in a secure location. Customers are to complete the Product Recall Inventory Form and fax it to the Customer Service Department. Customers are also to contact Customer Service for a Return Authorization Number at 1-866-2 |
| Quantity | 400 units |
| Distribution | Nationwide Distribution -- MI, PA, IL, & Washington, D.C. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000737 | COAXIAL DILATOR SET Xentek Medical, Inc., Aug 1, 2000 |