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Terminated

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.

FDA Recall Z-2261-2011 · Posted 2011-05-25

Recalling FirmNurse Assist, Inc
Recall StatusTerminated
Product CodeKOD
Date Initiated2011-01-20
Date Terminated2012-10-25
Product Quantity1504 cases

Reason for Recall

The trays contain Triad Group Sterile Lubricating Jelly packs recalled by Triad Group because of the possibility of inadequate sterilization.

Firm 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.

Root Cause

Other

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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