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Devices
Device Recall TrActive System Balloon Inflation Syringe
Model / Serial
Lot numbers: 47052 exp 11/30/06, 47645 exp 12/31/06, and 49128 exp 3/31/07
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide. The products are shipped to hospitals in AL, DE, Fl, IL, IN, MI, PA, SC, TN and TX.
Product Description
TriActiv System Balloon Inflation Syringe. The syringe packs/boxes contain 5 'spare' syringes.
Manufacturer
Kensey Nash Corp
1 Event
Recall of Device Recall TrActive System Balloon Inflation Syringe
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Manufacturer
Kensey Nash Corp
Manufacturer Address
Kensey Nash Corp, 735 Pennsylvania Dr, Exton PA 19341-1130
Source
USFDA
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