REORDER NO. 7305WTU (NON-STERILE) WELCON BRAND FOLEY CATHETER TRAY w/o Catheter w/10ml. Prefilled Syringe this product is intended to be sterilized by the end processor nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com Intended use: The trays are urological catheter trays.
FDA Recall Z-2276-2011 · Posted 2011-05-25
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Recalling FirmNurse Assist, Inc
Recall StatusTerminated
Product CodeFCM
Date Initiated2011-01-20
Date Terminated2012-10-25
Product Quantity32 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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