FDA Medical Device Recalls (openFDA)
Nurse Assist, Inc: Case Label: McKESSON Medi-Pak Ureteral Catheter Tray With Red Rubber Catheter Sterile Single Use Disposable 20 Trays Per Case Reorder No. 37-232 Marketed By McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Made in the U.S.A. Tray Label: McKESSON Medi-Pak Urethral Catheter Tray With Red Rubber Catheter Sterile Single Use Disposable Contents: 1-14 FR Red Rubber Catheter, 1-Pair of Vinyl Gloves, 1-Specimen Container with Lid and Label, 1-Fenestrated Drape, 1-Pack of Three PVP Swabsticks, 1-Pack of Lubricating Jelly, 1- Polylined Drape, 1-Graduated Tray, 1200 cc Reorder No. 37-232 Contents STERILE In unopened, undamaged package. Marketed By McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Intended use: The trays are urological catheter trays.
- Recall number
- Z-2263-2011
- Recalling firm
- Nurse Assist, Inc
- Product
- Case Label: McKESSON Medi-Pak Ureteral Catheter Tray With Red Rubber Catheter Sterile Single Use Disposable 20 Trays Per Case Reorder No. 37-232 Marketed By McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Made in the U.S.A. Tray Label: McKESSON Medi-Pak Urethral Catheter Tray With Red Rubber Catheter Sterile Single Use Disposable Contents: 1-14 FR Red Rubber Catheter, 1-Pair of Vinyl Gloves, 1-Specimen Container with Lid and Label, 1-Fenestrated Drape, 1-Pack of Three PVP Swabsticks, 1-Pack of Lubricating Jelly, 1- Polylined Drape, 1-Graduated Tray, 1200 cc Reorder No. 37-232 Contents STERILE In unopened, undamaged package. Marketed By McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Intended use: The trays are urological catheter trays.
- Status
- Terminated
- Initiated
- 2011-01-20
- Posted
- 2011-05-25
- Terminated
- 2012-10-25
- Reason
- The trays contain Triad Group Sterile Lubricating Jelly packs recalled by Triad Group because of the possibility of inadequate sterilization.
- 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
- 17,384 cases
- Distribution
- Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai and Saudi Arabia.
- Lot, serial or model codes
- Lot Codes: 804192, 808059, 809086, 810246, 812040, 812198, 902029, 902286, 904074, 905128, 906279, 907368, 908385, 909389, 911130, 912280, 1001222, 1003022, 1003390, 1004260, 1006033, 1007077, 1008230, 1010077, and 1011135.
- 510(k) numbers
- not on file
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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