Devices

Device Recall LifeStent 6mm LP SDS Billiary Endoprosthesis

Model / Serial
Lot numbers, FA0311031, FA0311032, FA0311034, FA0311035, FA0312026, FA0312034, FA0312041, FA0312042, FA0312051, FA0312052, FA0401006, FA0401019, FA0401026, FA0402026
Distribution
Product was shipped to one own label distributer in California.
Product Description
The product is a stainless steel stent mounted on a PTA balloon delivery device. The product is indicated for the palliation of malignant neoplasms in the biliary tree. || The product is labeled as Edwards Lifesciences, LifeStent LP SDS, Biliary Endoprosthesis. Manufactured by ORBUS, MEDICAL TECHNOLOGIES. 5363 NW 35th Ave, Fort Lauderdale, FL, 33309. Ph 954 730-071, www. orbus.com. || Distributed by: Edwards Lifesciences, Irvine, CA 82014-5888. || Ref. Baloon-Expandable Stent and delivery System. || Catalog Numbers || SD186U14D || SD186U24D || SD366U14D || SD366U24D
Manufacturer
Orbus Medical Technologies Inc
1 Event
- Recall of Device Recall LifeStent 6mm LP SDS Billiary Endoprosthesis

Manufacturer

Orbus Medical Technologies Inc

Manufacturer Address
Orbus Medical Technologies Inc, 5363 NW 35th Ave, Fort Lauderdale FL 33309-6315
Source
USFDA

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