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Manufacturers
Terumo Australia Pty Ltd
Manufacturer Parent Company (2017)
Terumo Corp.
Source
DHTGA
7 Events
Recall of U-100 Insulin Syringe 0.5mL 27G and 29G
Recall of FemoSeal Vascular Closure System
Recall of Various Terumo Introducer Kits Glide Shealth Slender Radifocus Introducer II (Femoral) Radifocus Introducer II M Coat (Transradial)
Recall of Terumo CDI Blood Parameter Monitoring System 500(Heart lung bypass in line blood gas monitor module)
Recall of Terumo CDI H/S Cuvette (used with the CDI Blood Parameter Monitoring System 500 during cardiopulmonary bypass)
Recall of A.V. Fistula sets for Haemodialysis - Safety AVF Needle fixed wing
Recall of Advanced Perfusion System 1 (heart-lung bypass machine)
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7 devices in the database
U-100 Insulin Syringe 0.5mL 27G and 29G
Model / Serial
U-100 Insulin Syringe 0.5mL 27G and 29G Lot Numbers for product SS*05M2713KA: 7D700, 7E700, 7F731, 7G719, 7I701, 6H713,6K700 Lot Numbers for product SS*05M2913KA : 7A713, 7G720, 7I7012, 7A713, 7B728, 6F700, 6F706Multiple Lot Numbers (see attached)ARTG: 234082 (Terumo Australia Pty Ltd - Insulin syringe, fixed-needle)
FemoSeal Vascular Closure System
Model / Serial
FemoSeal Vascular Closure SystemAll non-expired productProduct Code: C11202Multiple Lot NumbersARTG Number: 263892
Various Terumo Introducer Kits Glide Shealth Slender Radifocus Introducer II (Femoral) Radifocus ...
Model / Serial
Various Terumo Introducer Kits Glide Shealth SlenderRadifocus Introducer II (Femoral)Radifocus Introducer II M Coat (Transradial)Multiple Product Codes and Lot NumbersARTG Number: 126256
Terumo CDI Blood Parameter Monitoring System 500(Heart lung bypass in line blood gas monitor module)
Model / Serial
Terumo CDI Blood Parameter Monitoring System 500(Heart lung bypass in line blood gas monitor module)Catalogue numbers.: 500AHCT & 500AVHCTSerial numbers: 1899, 1948, 2473, 8001ARTG Number: 94012
Product Classification
Cardiovascular Devices
Terumo CDI H/S Cuvette (used with the CDI Blood Parameter Monitoring System 500 during cardiopulm...
Model / Serial
Terumo CDI H/S Cuvette (used with the CDI Blood Parameter Monitoring System 500 during cardiopulmonary bypass)Catalogue Numbers: 6912, 6913, 6914, 6922, 6923, 6924, CX-AU031XMultiple Lot Numbers affected (see attached)ARTG Number: 138712
2 more
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