Case Label: REF UT8150 Urethral Insertion Tray 14 Fr Red Rubber Catheter with PVP Swabs Qty: 20 For Rx Only Sterile unle

FDA device recall Z-2289-2011 · posted 2011-05-25 · Terminated

Recall details

Recalling firm

Nurse Assist, Inc

Reason for recall

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

Action taken

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

Status

Terminated

Product code

FCM

Quantity affected

1,496 cases

Distribution

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

Date initiated

2011-01-20

Date posted

2011-05-25

Date terminated

2012-10-25

Location

Fort Worth, TX