Z-2261-2011

Case Label: McKESSON Medi-Pak Uretheral Catheter Tray With Red Rubber Catheter Sterile Single Use Disposable...

Name: Z-2261-2011 Case Label: McKESSON Medi-Pak Uretheral Catheter Tray With Red Rubber Catheter Sterile Single Use Disposable...
Creator: Nurse Assist, Inc
Published: 2011-01-20
License: https://open.fda.gov/license/

Nurse Assist, LLC / initiated 2011-01-20 / Terminated / root cause: sterility

FDA source

Nurse Assist, Inc began a recall of Case Label: McKESSON Medi-Pak Uretheral Catheter Tray With Red Rubber Catheter Sterile Single Use Disposable 20 Trays Per Case Reorder No. 37-202 Marketed By... on 2011-01-20. The reason FDA records is "The trays contain Triad Group Sterile Lubricating Jelly packs recalled by Triad Group because of the possibility of inadequate sterilization". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2261-2011
Status: Terminated
Initiated: 2011-01-20
Posted: 2011-05-25
Terminated: 2012-10-25
Recalling firm: Nurse Assist, LLC
Product: Case Label: McKESSON Medi-Pak Uretheral Catheter Tray With Red Rubber Catheter Sterile Single Use Disposable 20 Trays Per Case Reorder No. 37-202 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: 1-14FR Red Rubber Catheter, 1-Pair of Vinyl Gloves, 1-Specimen Container with Lid and Label, 1-Fenestrated Drape, 1-Pack of PVP Solution, 1-Pack of Lubricating Jelly, 1-Pair of Forceps, 5-Rayon Balls in One Prep Cup, 1-Polylined Drape, 1-CSR Wrap, 1 Graduated Tray, 1200 cc Reorder No. 37-202 Contents STERILE In unopened, undamaged package. Marketed By McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Intended use: The trays are urological catheter trays.
Product code: KOD Catheter, Urological
Reason for recall: The trays contain Triad Group Sterile Lubricating Jelly packs recalled by Triad Group because of the possibility of inadequate sterilization.
Root cause tag: sterility
FDA 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 in commerce: 1504 cases
Distribution: Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai and Saudi Arabia.
Product codes and lots: Lot Codes: 809027, 812036, 901039, 902282, 903272, 903345, 906277, 908218, 909388, 911032, 912279, 1002027, 1003117, 1004345, 1006032, and 1007159

Product code KOD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)