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Devices
Device Recall Atrium
Model / Serial
Lot #s 10304311, 10321933, 10336423
Product Classification
General and Plastic Surgery Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution: USA, US Virgin Islands, South Africa, Austria, Taiwan, Venezuela, and Saudi Arabia.
Product Description
HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, || Atrium Code # 9016, || Size (Fr) 16, || # Eyelets 4, || 10 per case
Manufacturer
Atrium Medical Corporation
1 Event
Recall of Device Recall Atrium
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Manufacturer
Atrium Medical Corporation
Manufacturer Address
Atrium Medical Corporation, 5 Wentworth Dr, Hudson NH 03051-4929
Manufacturer Parent Company (2017)
Getinge AB
Source
USFDA
43 devices with a similar name
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Device Recall Atrium
Model / Serial
Lot 10311260
Product Classification
General and Plastic Surgery Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution: USA, US Virgin Islands, South Africa, Austria, Taiwan, Venezuela, and Saudi Arabia.
Product Description
HydraGlide Heparin Coated Silicone Thoracic Catheters - Mediastinal, Eyes on Top & Bottom, || Atrium Code # 14509, || Size 9mm, || # Eyelets 9, || 10 per case
Manufacturer
Atrium Medical Corporation
Device Recall Atrium
Model / Serial
Lot # 10327130
Product Classification
General and Plastic Surgery Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution: USA, US Virgin Islands, South Africa, Austria, Taiwan, Venezuela, and Saudi Arabia.
Product Description
HydraGlide Heparin Coated Silicone Thoracic Catheters - Mediastinal, Eyes on Top, || Atrium Code # 14709, || Size 9mm, || # Eyelets 6, || 10 per case
Manufacturer
Atrium Medical Corporation
Device Recall Atrium
Model / Serial
Lot # 10311107
Product Classification
General and Plastic Surgery Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution: USA, US Virgin Islands, South Africa, Austria, Taiwan, Venezuela, and Saudi Arabia.
Product Description
HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9012, Size (Fr) 12, # Eyelets 4, 10 per case
Manufacturer
Atrium Medical Corporation
Device Recall Atrium
Model / Serial
Lot #s 10321934,10336528,10337106
Product Classification
General and Plastic Surgery Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution: USA, US Virgin Islands, South Africa, Austria, Taiwan, Venezuela, and Saudi Arabia.
Product Description
HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, || Atrium Code # 9020, || Size (Fr) 20, || # Eyelets 4, || 10 per case
Manufacturer
Atrium Medical Corporation
Device Recall Atrium
Model / Serial
Lot #s 10311122, 10321935,10342004,10348451
Product Classification
General and Plastic Surgery Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution: USA, US Virgin Islands, South Africa, Austria, Taiwan, Venezuela, and Saudi Arabia.
Product Description
HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, || Atrium Code # 9024, || Size (Fr) 24, || # Eyelets 5, || 10 per case
Manufacturer
Atrium Medical Corporation
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