StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.
Reported: February 22, 2017 Initiated: February 10, 2017 #Z-1202-2017
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.
Details
- Recalling Firm
- Abbott Vascular
- Units Affected
- 170,008 units total (83,029 units in US)
- Distribution
- US: Germany, Italy, Puerto Rico, Spain, Sweden, Switzerland,
- Location
- Temecula, CA
Frequently Asked Questions
What product was recalled? ▼
StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.. Recalled by Abbott Vascular. Units affected: 170,008 units total (83,029 units in US).
Why was this product recalled? ▼
Abbott Vascular is recalling the StarClose SE Vascular Closure System because it may exhibit difficulty or failure to deploy the StarClose SE Clip.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 22, 2017. Severity: Moderate. Recall number: Z-1202-2017.
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