FDA Medical Device Recalls (openFDA)
Nurse Assist, Inc: Case Label: REORDER NO. 6112 STERILE WELCON BRAND 60cc PISTON SYRINGE With Sterile Water 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com Tray Label: REORDER NO. 6112 STERILE UNLESS OPENED OR DAMAGED nurse assist incorporated A6009, R1 WELCON BRAND SINGLE USE Thumb Control Ring Piston Syringe With 100 mL Sterile Water 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com CONTENTS: 1200 mL Graduated Drain Tray 100 mL Sterile Water 60cc Thumb Control Ring Syringe Tip Protector Antiseptic Wipe Waterproof Underpad Intended use: The trays are irrigation trays for catheters
- Recall number
- Z-2256-2011
- Recalling firm
- Nurse Assist, Inc
- Product
- Case Label: REORDER NO. 6112 STERILE WELCON BRAND 60cc PISTON SYRINGE With Sterile Water 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com Tray Label: REORDER NO. 6112 STERILE UNLESS OPENED OR DAMAGED nurse assist incorporated A6009, R1 WELCON BRAND SINGLE USE Thumb Control Ring Piston Syringe With 100 mL Sterile Water 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com CONTENTS: 1200 mL Graduated Drain Tray 100 mL Sterile Water 60cc Thumb Control Ring Syringe Tip Protector Antiseptic Wipe Waterproof Underpad Intended use: The trays are irrigation trays for catheters
- Status
- Terminated
- Initiated
- 2011-01-20
- Posted
- 2011-05-25
- Terminated
- 2012-10-25
- Reason
- The irrigation procedure trays contain Triad Group Alcohol Prep Pads recalled by Triad Group because they have the potential to be contaminated with an objectionable organism.
- Root cause
- Other
- Action
- The firm, Nurse Assist Incorporated, sent a letter dated January 20, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory immediately; quarantine the product; identify their customers and notify them at once about the product recall (Nurse Assist will provide bright labels to affix to your affected inventory); provide their customers with labels as well, and complete and return the attached RECALL ACKNOWLEGEMENT form via fax to: 817-231-1500 or mail to: Nurse Assist, Inc., 3400 Northern Cross Blvd., Forth Worth, TX 76137. Only the product and lots identified on the attached list are affected. If you have any questions or to request labels, please call Nurse Assist Customer Service Monday through Friday, from 8:00 am to 5:00 pm Central Time at 1-800-649-6800.
- Quantity
- 640 cases
- Distribution
- Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai and Saudi Arabia.
- Lot, serial or model codes
- Lot Codes: 902103, 908040, 908311, 909190, 911414, 1001028, 1003198, and 1005142
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FCM
- Firm FEI
- 3002695476
- Firm city
- Fort Worth
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28