6 F BardSelect 11cm Percutaneous Catheter Introducer Set Ref: 060A11 Percutaneous catheter introducer sets, including sh
FDA device recall Z-0442-2009 · posted 2008-12-02 · Terminated
Recall details
- Recalling firm
- Medtronic, Inc.
- Reason for recall
- Failure to insert the guidewire through the 18 gauge introducer needle
- Action taken
- Medtronic notified Medtronic Sales representatives via UPS for hand delivery of the Urgent Notification of Product Recall letter to the affected customers on 10/7/08 advising users to segregate the product so that it would not be used. The letter stated that a Medtronic Sales Rep would visit the site to account for all units that were received and would initiate a credit, as appropriate. Customers were requested to cooperate and assist with completing the necessary documentation.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 2,585 units
- Distribution
- Worldwide Distribution --- USA including states of IL and FL, and countries of Belgium, Honduras, and Germany.
- Date initiated
- 2008-10-07
- Date posted
- 2008-12-02
- Date terminated
- 2011-06-07
- Location
- Danvers, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TS PERCUTANEOUS ARTERIAL/VENUS CATHETER INTRO SET (K955785) | C.R. Bard, Inc. | 1996-03-12 |