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Devices
Polystan Coronary Cannula Balloon Tip. (Cardiopulmonary bypass vascular catheter).
Model / Serial
Lot numbers: 162119; 162572; 163299; 164050; 165934; 167444; 167446; 171658; 176841; 178282; 179626; 180352; 180822; 184419; 185618; 186149; 187100; 188865.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide. Maquet Cardiopulmonary AG, Hirrlingen, Germany has one US distributor, Surgemedical Inc., Holland, Michigan. The firm is to return all cannula in their possession back to Maquet.
Product Description
Polystan Coronary Cannula Balloon Tip. (Cardiopulmonary bypass vascular catheter).
Manufacturer
Maquet Inc
1 Event
Recall of Polystan Coronary Cannula Balloon Tip. (Cardiopulmonary bypass vascular catheter).
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Manufacturer
Maquet Inc
Manufacturer Address
Maquet Inc, 1140 Route 22 East, Bridgewater NJ 08807-2912
Source
USFDA
Language
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