Percutaneous Catheter Introducer Set, VNUS Medical Technologies Cath Shth Intro 7F x 7cm, catalog number IS-7F07, Dispos
FDA device recall Z-0764-2010 · posted 2010-02-02 · Terminated
Recall details
- Recalling firm
- Argon Medical Devices, Inc
- Reason for recall
- One lot of Percutaneous Catheter Introducer Set contained incorrect size needle.
- Action taken
- Firm notified sole consignee by an Urgent Medical Device Recall certified letter dated 1/6/2010. The letter identified the product being recalled and asked the consignee to immediately quarantine any product remaining at their facility. The recall should be conducted to the user level. Affected products at the consignee's facility and with their customers, should be returned using the instructions on the response form. The response forms are to completed and returned by fax or e-mail as indicated. Questions or the need for additional information concerning this recall should be directed to Sarah Larson at 903-677-9351 or Sarah.Larson@argonmedical.com.
- Root cause
- Other
- Status
- Terminated
- Product code
- DRE
- Quantity affected
- 500 units
- Distribution
- Nationwide Distribution -- State of CA.
- Date initiated
- 2009-01-06
- Date posted
- 2010-02-02
- Date terminated
- 2010-07-14
- Location
- Athens, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DILATOR, VESSEL & INTRODUCER, SHEATH (K780126) | Argon Medical Corp. | 1978-03-02 |