Micro Introducer Kit 5F, Model number: KIT-014-29, & Customer Model number: 7204. Vascular Solutions, 6464 Sycamore Cour
FDA device recall Z-1592-2010 · posted 2010-05-11 · Terminated
Recall details
- Recalling firm
- Galt Medical Corp
- Reason for recall
- Potential problem with pouch seal thus affecting sterile product.
- Action taken
- 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 1-866-240-6001. Affected products will be replaced upon receipt. Questions or concerns should be directed to a local Sales Representative or Jill Eisenzimmer, Product Manager, at 763-656-4300.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- DRE
- Quantity affected
- 400 units
- Distribution
- Nationwide Distribution -- MI, PA, IL, & Washington, D.C.
- Date initiated
- 2010-02-08
- Date posted
- 2010-05-11
- Date terminated
- 2011-03-21
- Location
- Garland, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COAXIAL DILATOR SET (K000737) | Xentek Medical, Inc. | 2000-08-01 |