Percutaneous Catheter Introducer Set, VNUS Medical Technologies Cath Shth Intro 7F x 7cm, catalog number IS-7F07, Disposable, Single Use, Do Not Re-sterilize, Manufactured in USA for VNUS, 5799 Fontanus Way, San Jose CA 95138 USA; General: 408-360-7200. For catheter exchange or placement of closed end catheters utilizing the Desilets-Hoffman technique.
FDA Recall Z-0764-2010 · Posted 2010-02-02
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Recalling FirmArgon Medical Devices, Inc
Recall StatusTerminated
Product CodeDRE
Date Initiated2009-01-06
Date Terminated2010-07-14
Product Quantity500 units
Reason for Recall
One lot of Percutaneous Catheter Introducer Set contained incorrect size needle.
Firm Action
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 [email protected].
Root Cause
Other
Distribution Pattern
Nationwide Distribution -- State of CA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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