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Devices
Portex Per-Fit Percutaneous Dilational Tracheostomy Kit, ID 8.0mm || Product Number: 535080
Model / Serial
Lot Numbers: K515073, K515074, K515075, K518076, K518077, K520176, K523556, K527903, K548745, K559483, K614996, K630177
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
Natiowide Foreign: Canada, Mexico and East Timor.
Product Description
Portex Per-Fit Percutaneous Dilational Tracheostomy Kit, ID 8.0mm || Product Number: 535080
Manufacturer
Smiths Medical ASD, Inc.
1 Event
Recall of Portex Per-Fit Percutaneous Dilational Tracheostomy Kit, ID 8.0mm || Product Number: 535080
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Manufacturer
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
Language
English
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