Recall Z-1202-2017— Abbott Vascular
Class II · Terminated
Class II FDA medical device recall by Abbott Vascular, initiated 2017-02-10, terminated 2017-12-06. FDA's recall record names no specific 510(k) clearance for this event. Product: StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.. Reason: Abbott Vascular is recalling the StarClose SE Vascular Closure System because it may exhibit difficulty or failure to deploy the StarClose SE Clip..
- Recalling firm
- Abbott Vascular
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-02-10
- Terminated
- 2017-12-06
- Firm location
- Temecula, CA, United States
Product description
StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.
Reason for recall
Abbott Vascular is recalling the StarClose SE Vascular Closure System because it may exhibit difficulty or failure to deploy the StarClose SE Clip.
Data sourced from openFDA. This site is unofficial and independent of the FDA.