Hickman 9.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system
FDA device recall Z-0909-2013 · posted 2013-03-06 · Terminated
Recall details
- Recalling firm
- Bard Access Systems
- Reason for recall
- Bard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 French Dual Lumen Catheters with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer Systems due to the wrong size introducer being included with the kit.
- Action taken
- Bard sent an Urgent Recall Notification letters dated February 2013 to all affected customers. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to examine their inventory for the affected product, return any remaining in stock and complete the enclosed Reply Form and Inventory Reconciliation Form. For questions contact Bard Access Systems Customer Service at 1-800-290-1689.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 195 units.
- Distribution
- USA Nationwide Distribution and the countries Europe, Belgium, Australia, and Latin America.
- Date initiated
- 2013-02-21
- Date posted
- 2013-03-06
- Date terminated
- 2014-01-03
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NON-STERILE,SINGLE/SOUBLE LUMEN-CATH (K830233) | Evermed, Inc. | 1983-02-28 |