Devices

Device Recall Glidesheath Slender Hydrophilic Coated Introducer Sheath

Model / Serial
Lot s 161019, 161108, 161215, 170112, 170213, 170314
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide and Canada
Product Description
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 16CM (0.021), REF/Product Code RM*RS7F16PA, STERILE, Rx ONLY
Manufacturer
Terumo Medical Corp
1 Event
- Recall of Device Recall Glidesheath Slender Hydrophilic Coated Introducer Sheath

Manufacturer

Terumo Medical Corp

Manufacturer Address
Terumo Medical Corp, 2101 Cottontail Ln, Somerset NJ 08873-1277
Manufacturer Parent Company (2017)
Terumo Corp.
Source
USFDA

16 devices with a similar name

Learn more about the data here

Device Recall Glidesheath Slender Hydrophilic Coated Introducer Sheath

Model / Serial
Lot s 161018, 161116, 161117, 161213, 161214, 170118, 170119
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide and Canada
Product Description
Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.025), REF/Product Code RM*ES6J10HAT, STERILE, Rx ONLY
Manufacturer
Terumo Medical Corp

Device Recall Glidesheath Slender Hydrophilic Coated Introducer Sheath

Model / Serial
Lot s 161019, 161115, 161212, 170112
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide and Canada
Product Description
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*RS5F10PA, STERILE, Rx ONLY
Manufacturer
Terumo Medical Corp

Device Recall Glidesheath Slender Hydrophilic Coated Introducer Sheath

Model / Serial
Lot s 161107, 170209, 170307, 170406
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide and Canada
Product Description
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 16CM (0.021), REF/Product Code RM*RS5F16PA, STERILE, Rx ONLY
Manufacturer
Terumo Medical Corp

Device Recall Glidesheath Slender Hydrophilic Coated Introducer Sheath

Model / Serial
Lot 170113
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide and Canada
Product Description
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.025), REF/Product Code RM*RS5J10PA, STERILE, Rx ONLY
Manufacturer
Terumo Medical Corp

Device Recall Glidesheath Slender Hydrophilic Coated Introducer Sheath

Model / Serial
Lot 161104
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide and Canada
Product Description
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*CS5F10NA, STERILE, Rx ONLY
Manufacturer
Terumo Medical Corp

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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