Devices

Device Recall SafeSheath Long, (TearAway Sheath Introducer Set with Integral Hemostasis Valve)

Model / Serial
Part No. FCL-051-00, Catalog No. HLS2507MCN, Lot #S33309; and Part No. FCL-051-02, Catalog No. HLS2507MCN, Lot #S33308.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Distribution Nationwide USA and Germany.
Product Description
Thomas Medical Products, SafeSheath Long, (Tear-Away Sheath Introducer Set with Integral Hemostasis Valve) for use during vascular interventional procedures. Part No. FCL-051-00, Catalog No. HLS2507MCN; and Part No. FCL-051-02, Catalog No. HLS2507MCN.
Manufacturer
Thomas Medical Products Inc
1 Event
- Recall of Device Recall SafeSheath Long, (TearAway Sheath Introducer Set with Integral Hemostasis Valve)

Manufacturer

Thomas Medical Products Inc

Manufacturer Address
Thomas Medical Products Inc, 65 Great Valley Pkwy, Malvern PA 19355-1302
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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