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Terminated

WELCON TM BRAND REORDER NO. 7401 (STERILE) URETHRAL CATHETER KIT With 3 Compartment Plastic Pouch. LOT 25 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com URETHRAL CATHETER KIT With 3 Compartment Plastic Pouch

FDA Recall Z-0499-2012 · Posted 2012-01-11

Recalling FirmNurse Assist, Inc
Recall StatusTerminated
Product CodeKOD
Date Initiated2011-09-02
Date Terminated2012-10-26
Product Quantity1765 cases

Reason for Recall

Nurse Assist, Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays.

Firm Action

Nurse Assist sent a recall notice dated September 2, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory immediately and quarantine the affected product. Customers were also instructed to identify their customers and notify them at once of the product recall. Customers were instructed to complete and return the enclosed response form as soon as possible. For those distributors that choose to destroy the affected product they must use the attached Notice of Destruction to report the specifics of the destroyed product. and contact Nurse Assist Customer Service for a RGA # prior to destruction. For any questions call Nurse Assist Customer Service at 1-800-649-6800.

Root Cause

Component design/selection

Distribution Pattern

Worldwide Distribution - USA (nationwide) and the countries of Canada and Saudi Arabia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

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