Kensey Nash Corp

Catalog number 63000-01, Lot number 57292 exp March 2008

Cardiovascular Devices

2

No

Nationwide:The products were shipped to medical facilities in FL, MO, NJ, and TX.

ThromCat Thrombectomy Catheter System. Catalog number 63000-01

Catalog number 61030-01, Lot number 56662 exp 2/28/08

General and Plastic Surgery Devices

Unclassified

No

Worldwide, including USA and Germany.

ProGuard Spare Shieldwire Inflators (2.5 - 5.0 mm), Catalog number 61030-01. The product is sold 5 per box.

Catalog number 60042-02. Lot numbers 49320 exp 4/30/07, 51710 exp 7/31/07, 52340 exp 8/31/07, 52884 exp 9/30/07, 53210 exp 10/31/07, and 53614 exp 10/31/07

General and Plastic Surgery Devices

Unclassified

No

Worldwide, including USA and Germany.

FX Spare Shieldwire Inflators (3.0 - 5.0 mm), Catalog number 60042-02. The product is sold 5 per box.

Catalog numbers 60040-02 and 60040-03. Lot numbers 49709 exp 3/31/07, 51844 exp 5/31/07, 52822 exp 7/31/07, 53209 exp 5/31/07, 53252 exp 7/31/07, 54264 exp 7/31/07, 54276 exp 11/30/07, 49912 exp 3/30/07, 50952 exp 5/31/07, 51714 exp 7/31/07, 52488 exp 5/31/07, and 54248 exp 11/30/07.

General and Plastic Surgery Devices

Unclassified

No

Worldwide, including USA and Germany.

TriActiv FX Embolic Protection System 7F, Catalog numbers 60040-02 (has 190 cm guidewire) and 60040-03 (has 300 cm guidewire). The devices are comprised of four principal components including the ShieldWire Balloon Guidewire, the Shieldwire Inflator, the FX or LFX Catheter, and the AutoStream Flow Control.

Part number 61000-01. Lot number 48275 exp 1/07

Cardiovascular Devices

2

No

The product was shipped to hospitals in Germany and Italy.

TriActiv ProGuard Embolic Protection System, Part number 61000-01. The product is shipped as a procedure kit. It is used with a standard 6F guide catheter using the standard femoral approach.