McKESSON Medi-Pak Urethral Catheter Tray with Plastic Catheter Sterile.Single Use.Disposable.Latex-Free 20 Trays Per Cas
FDA device recall Z-0490-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Nurse Assist, Inc
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- KOD
- Quantity affected
- 11,048 cases
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Canada and Saudi Arabia.
- Date initiated
- 2011-09-02
- Date posted
- 2012-01-11
- Date terminated
- 2012-10-26
- Location
- Fort Worth, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STERILE CATHERIZATION PROCEDURE TRAYS (K830359) | Welcon, Inc. | 1983-03-17 |