FDA Medical Device Recalls (openFDA)
Nurse Assist, Inc: WELCON TM BRAND REORDER NO. 8012 (STERILE) CATHETER CARE KIT 60 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com CATHETER CARE KIT
- Recall number
- Z-0501-2012
- Recalling firm
- Nurse Assist, Inc
- Product
- WELCON TM BRAND REORDER NO. 8012 (STERILE) CATHETER CARE KIT 60 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com CATHETER CARE KIT
- Status
- Terminated
- Initiated
- 2011-09-02
- Posted
- 2012-01-11
- Terminated
- 2012-10-26
- Reason
- Nurse Assist, Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays.
- Root cause
- Component design/selection
- Action
- Nurse Assist sent a recall notice dated September 2, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory immediately and quarantine the affected product. Customers were also instructed to identify their customers and notify them at once of the product recall. Customers were instructed to complete and return the enclosed response form as soon as possible. For those distributors that choose to destroy the affected product they must use the attached Notice of Destruction to report the specifics of the destroyed product. and contact Nurse Assist Customer Service for a RGA # prior to destruction. For any questions call Nurse Assist Customer Service at 1-800-649-6800.
- Quantity
- 120
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Canada and Saudi Arabia.
- Lot, serial or model codes
- Assembly ID 8012. Lot Numbers: 911124 and 1007326. Pack Lot #s: 36146 and 37273.
- 510(k) numbers
- ["K830359"]
- PMA numbers
- not on file
- Product code
- KOD
- 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