Recall Z-2670-2014 ยท NGT Saline, Vascular Access Flush
Centurion Medical Products Corporation
0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe 10 mL REF#306553 used in Centurion Convenience Kits. Recalled product is attached to the outside of the Convenience Kits.
| Date | Sep 19, 2014 (initiated Jul 25, 2014) |
| Status | Terminated |
| Reason | Unit packages may exhibit open seals which impacts package integrity and potentially product sterility. |
| Root cause | Packaging |
| Action | Centurion sent an Urgent Product Recall Notice dated July 25, 2014, to all affected customers via Certified Mail. The notification discussed the affected product issue and provided instructions for initiating product return. Customers were instructed to identify and remove all inventory of these kits that they may have within their possession. Customers were asked to forward a copy of the notice to any customers to whom this product may have been further distributed. Customers were also asked to complete the enclosed accountability record, whether or not they have the product, and fax or e |
| Quantity | 21388 |
| Distribution | The product was distributed domestically to the following states: UT, WI, TX, NE, AZ, CA, IA, MD, NY, OK, PA, TN, TX, VA, NC, IL, MA, OR, WA, IN, SD. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042061 | 0.9% SODIUM CHLORIDE INJECTION, USP BD POSTFLUSH SF FLUSH SYRINGE Becton Dickinson, Aug 26, 2004 |