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Manufacturers
Smiths Medical ASD, Inc.
Manufacturer Address
Smiths Medical ASD, Inc., 5700 W 23rd Ave, Gary IN 46406-2617
Manufacturer Parent Company (2017)
Smiths Group Plc
Source
USFDA
28 Events
Recall of Device Recall Custom Made Tracheostomy Device
Recall of Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tubes, sterile, Product 67HA70.
Recall of Bivona brand Neonatal TTS Tracheostomy Tubes, sterile, product code 67N040.
Recall of Device Recall Hyperflex
Recall of Device Recall Hyperflex
Recall of Device Recall Hyperflex
Recall of Device Recall Smiths Bivona Adult Trach Tube
Recall of Device Recall Bivona Tracheostomy Tube
Recall of Device Recall Bivona Laryngectomy Tube
Recall of Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm tracheostomy tubes with a 3.5mm obturator ; product code 67P035.
Recall of Bivona brand Cuffless Extra Length Fixed Hyperflex Adult Tracheostomy Tube, 110 mm, sterile, Product code 60AFHXL70.
Recall of Bivona
Recall of Device Recall Bivona TTS Cuffed Neonatal Tracheostomy Tube
Recall of Device Recall Bivona TTS Cuffed Neonatal Tracheostomy Tube
Recall of Device Recall Bivona AireCuf Pediatric Tracheostomy Tube
Recall of Device Recall Bivona AireCuf Pediatric Tracheostomy Tube
Recall of Device Recall Bivona Uncuffed Neonatal Flex Tend Plus Tracheostomy Tube
Recall of Device Recall Bivona Uncuffed Neonatal Flex Tend Plus Tracheostomy Tube
Recall of Device Recall Bivona Uncuffed Pediatric Flex Tend Plus Standard Tracheostomy Tube
Recall of Device Recall Bivona Uncuffed Pediatric Flex Tend Plus Standard Tracheostomy Tube
Recall of Device Recall Bivona Uncuffed Pediatric Flex Tend Plus Extra Length Tracheostomy Tube
Recall of Device Recall Bivona Uncuffed Pediatric Flex Tend Plus Extra Length Tracheostomy Tube
Recall of Device Recall Bivona TTS Cuffed Pediatric Tracheostomy Tube
Recall of Device Recall Bivona TTS Cuffed Pediatric Tracheostomy Tube
Recall of Device Recall Bivona Uncuffed Pediatric Tracheostomy Tube
Recall of Device Recall Bivona Uncuffed Pediatric Tracheostomy Tube
Recall of Device Recall Bivona Uncuffed Neonatal Tracheostomy Tube
Recall of Device Recall Bivona Uncuffed Neonatal Tracheostomy Tube
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28 devices in the database
Device Recall Custom Made Tracheostomy Device
Model / Serial
GS025081
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
International Distribution to:Germany
Product Description
Custom Made Tracheostomy Device || The CADD Administration Sets with Flow Stop are designed to be used with a variety of CADD ambulatory infusion pumps to allow fluid delivery from an IV bag.
Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tubes, sterile, Product 67HA70.
Model / Serial
Lot G667991.
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide.
Product Description
Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tubes, sterile, Product 67HA70.
Bivona brand Neonatal TTS Tracheostomy Tubes, sterile, product code 67N040.
Model / Serial
Lot 1338010.
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
Georgia, Illinois, Indiana, Maryland, Tennessee, Texas and Virginia.
Product Description
Bivona brand Neonatal TTS Tracheostomy Tubes, sterile, product code 67N040.
Device Recall Hyperflex
Model / Serial
Lot G706181.
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide and Canada.
Product Description
Bivona brand Mid-Range Aire-Cuf Adjustable Neck Flange Hyperflex Tracheostomy Tube, I.D. 6.0 mm O.D. 8.7 mm length 110 mm; REF 75HA60.
Device Recall Hyperflex
Model / Serial
Lots G711870 and G711871.
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide and Canada.
Product Description
Bivona brand Mid-Range Aire-Cuf Extra Length Fixed Hyperflex Adult Tracheostomy Tube, I.D. 8.0 mm O.D. 11.0mm length 120 mm; REF 75FHXL80.
23 more
13 manufacturers with a similar name
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Smiths Medical Asd, Inc.
Manufacturer Parent Company (2017)
Smiths Group Plc
Source
NIDFSINVIMA
Smiths Medical ASD, Inc.
Manufacturer Address
Smiths Medical ASD, Inc., 10 Bowman Dr, Keene NH 03431-5043
Manufacturer Parent Company (2017)
Smiths Group Plc
Source
USFDA
Smiths Medical ASD, Inc.
Manufacturer Address
Smiths Medical ASD, Inc., 1265 Grey Fox Rd, Saint Paul MN 55112-6929
Manufacturer Parent Company (2017)
Smiths Group Plc
Source
USFDA
Smiths Medical ASD, Inc.
Manufacturer Address
Smiths Medical ASD, Inc., 160 Weymouth St, Rockland MA 02370-1136
Source
USFDA
Smiths Medical ASD, Inc.
Manufacturer Parent Company (2017)
Smiths Group Plc
Source
MHSIDCCCDMIS
8 more
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