Devices

Device Recall Welcon

Model / Serial
Lot Codes: 805072, 807274, 901104, 905134, 909392, 1007261, and 1010081.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai and Saudi Arabia.
Product Description
Case Label: REORDER NO. 7305 (STERILE) WELCON BRAND FOLEY CATHETER TRAY w/o Catheter w/10ml. Prefilled Syringe nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com || Tray Label: REORDER NO. 7305 STERILE UNLESS OPENED OR DAMAGED SINGLE USE WELCON BRAND Foley Catheterization Tray With 10 mL Prefilled Syringe 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com LatexFREE CONTENTS: 1200 mL Graduated Drain Tray 10 mL Prefilled Syringe Gloves Fenestrated Drape PVP Swabsticks (3) Lube Jelly Specimen Container and Label Waterproof Underpad || Intended use: The trays are urological catheter trays.
Manufacturer
Nurse Assist, Inc
1 Event
- Recall of Device Recall Welcon

Manufacturer

Nurse Assist, Inc

Manufacturer Address
Nurse Assist, Inc, 3400 Northern Cross Blvd, Fort Worth TX 76137-3600
Manufacturer Parent Company (2017)
Nurse Assist Inc.
Source
USFDA

25 devices with a similar name

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Device Recall WELCON

Model / Serial
Lot codes: 812083, 901041, 904254, 907192, 908039, 911228, 912190, 1003293, 1004168, and 1005018
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai and Saudi Arabia.
Product Description
Case Label: REORDER NO. 6101 STERILE WELCON BRAND Standard Irrigation Tray Clear-Vu Bulb Syringe 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com || Product Label: REORDER NO. 6101 STERILE UNLESS OPENED OR DAMAGED nurse assist incorporated A6031, R1 WELCON BRAND SINGLE USE Standard Irrigation Tray With Clear-Vu Bulb Syringe 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com LatexFree CONTENTS: 1200 mL Graduated Drain Tray 500 mL Graduate Bulb Syringe Waterproof Underpad Prep Pad Protective Cap || Intended use: The trays are irrigation trays for catheters
Manufacturer
Nurse Assist, Inc

Device Recall Welcon

Model / Serial
Lot Codes: 808244, 811011, 812145, 902102, 903108, 904077, 905023, 906198, 907079, 907279, 908130, 909284, 910265, 912282, 1001224, 1002216, 1003119, 1004169, 1005224, and 1006295.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai and Saudi Arabia.
Product Description
Case Label: REORDER NO. 6102 STERILE WELCON BRAND Standard Irrigation Tray Thumb Control Ring Piston Syringe 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com || Product Label: REORDER NO. 6102 STERILE UNLESS OPENED OR DAMAGED nurse assist incorporated A6000, R1 WELCON BRAND Standard Irrigation Tray With Piston Syringe SINGLE USE 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com CONTENTS: Underpad 500 mL Graduate 1200 mL Graduated Tray 60cc Thumb Ring Piston Syringe Tip Protector Alcohol Wipe || Intended use: The trays are irrigation trays for catheters
Manufacturer
Nurse Assist, Inc

Device Recall Welcon

Model / Serial
Lot Codes: 807273, 905024, 906282, 907280, 912370, 1002312, and 1005310.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai and Saudi Arabia.
Product Description
Case Label: REORDER NO. 6103 STERILE WELCON BRAND Economy Irrigation Tray Standard Green Bulb Syringe 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com || Tray Label: REORDER NO. 6103 STERILE UNLESS OPENED OR DAMAGED nurse assist incorporated A6001, R1 WELCON BRAND Economy Irrigation Tray With Bulb Syringe SINGLE USE 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com || Intended use: The trays are irrigation trays for catheters
Manufacturer
Nurse Assist, Inc

Device Recall Welcon

Model / Serial
Lot Codes: 811135, 901100, 903178, 909285, and 1004170.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai and Saudi Arabia.
Product Description
Case Label: REORDER NO. 6104 STERILE WELCON BRAND Economy Irrigation Tray Grommetless Poly-Pro Piston Syringe 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com || Tray Label: REORDER NO. 6104 STERILE UNLESS OPENED OR DAMAGED nurse assist incorporated A6011, R1 WELCON BRAND Economy Irrigation Tray With Grommetless Piston Syringe SINGLE USE 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com CONTENTS: Graduated Drain Tray 500 mL Graduate Grommetless Piston Syringe Waterproof Underpad Prep Pad || Intended use: The trays are irrigation trays for catheters
Manufacturer
Nurse Assist, Inc

Device Recall Welcon

Model / Serial
Lot Code:
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai and Saudi Arabia.
Product Description
REORDER NO. 6111 STERILE WELCON BRAND 60cc BULB SYRINGE With Sterile Water 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com || Intended use: The trays are irrigation trays for catheters
Manufacturer
Nurse Assist, Inc

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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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