Nurse Assist, Inc: Case Label: McKESSON Medi-Pak LATEX FREE Foley Catheter Tray Without Catheter For Use With 30 cc Foley Catheter Sterile Single Use Disposable Latex-Free 20 Trays Per Case Reorder No. 37-234 Marketed By McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Made in the U.S.A. Tray Label: McKESSON Medi-Pak LATEX FREE Foley Catheter Tray Without Catheter For Use With 30 cc Foley Catheter Sterile Single Use Disposable Latex-Free Contents: 1-Graduated Tray, 1200 cc, 1-Pair of Vinyl Gloves, 1-Fenestrated Drape, 1-Pack of Three PVP Swabsticks, 1-Specimen Container with Lid and Label, 1-Polylined Drape, 1-Pack of Lubricating Jelly, 1-30 cc Syringe, Pre-Filled with Sterile Water Reorder No. 37-234 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-2264-2011

Recalling firm

Nurse Assist, Inc

Product

Case Label: McKESSON Medi-Pak LATEX FREE Foley Catheter Tray Without Catheter For Use With 30 cc Foley Catheter Sterile Single Use Disposable Latex-Free 20 Trays Per Case Reorder No. 37-234 Marketed By McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Made in the U.S.A. Tray Label: McKESSON Medi-Pak LATEX FREE Foley Catheter Tray Without Catheter For Use With 30 cc Foley Catheter Sterile Single Use Disposable Latex-Free Contents: 1-Graduated Tray, 1200 cc, 1-Pair of Vinyl Gloves, 1-Fenestrated Drape, 1-Pack of Three PVP Swabsticks, 1-Specimen Container with Lid and Label, 1-Polylined Drape, 1-Pack of Lubricating Jelly, 1-30 cc Syringe, Pre-Filled with Sterile Water Reorder No. 37-234 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

6,696 cases

Distribution

Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai and Saudi Arabia.

Lot, serial or model codes

Lot Codes:804263, 807270, 808179, 810076, 811187, 812142, 902100, 903176, 904167, 905273, 906315, 908128, 908386, 910264, 911413, 912281, 1001318, 1003023, 1003391, 1004261, 1005222, 1006360, 1007329, 1010149, and 1011136.

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

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

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