Recall Z-2352-2011 ยท MCY Wound Dressing Kit
Centurion Medical Products Corporation
Material DT9155, PORT ACCESS TRAY W/SORBAVIEW&CHLORAPREP, CENTURION PORT ACCESS TRAY WITH SORBAVIEW AND CHLORAPREP, REORDER DT9155, STERILE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800.248.4058 www.centurionmp.com FACILITATES PORT INSERTION
| Date | May 27, 2011 (initiated Mar 31, 2011) |
| Status | Terminated |
| Reason | This voluntary sub-recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP, 0.9% utilized to make the products may contain visible particulates. |
| Root cause | Material/Component Contamination |
| Action | Centurion Medical Products Corporation issued press on April 1, 2011, and sent an Urgent Voluntary Recall letter dated March 15, 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 discontinue use of the kits immediately and instructions were provided for the return of the kits. Customers were also asked to complete a form to fax or email back to the firm regarding the number of kits the firm has in their possession. Customers were instructed to provide recall notification to other firm's w |
| Quantity | 660 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.