Recall Z-0596-2012 ยท NGT Saline, Vascular Access Flush
Hospira Inc.
0.9% Sodium Chloride Injection, USP, pre-filled flush solution, for IV Flush only, sterile fluid path; 10 mL Single-Use Syringe with Male Luer Lock, 100 syringes per pack, 4 packs per case; Made in Costa Rica, Hospira, Inc., Lake Forest, IL 60045 USA; list no. 1978-20 lock flush solution
| Date | Jan 11, 2012 (initiated Nov 18, 2011) |
| Status | Terminated |
| Reason | There is particulate matter in the fluid pathway, which has been identified as the same material as the rubber tip of the syringe plunger. |
| Root cause | Material/Component Contamination |
| Action | Hospira sent a "URGENT DEVICE RECALL" letter dated November 18, 2011, to all affected customers via UPS. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to check their inventory and immediately quarantine any affected product complete and return Reply Form via fax to 1-866-912-2512. Return affected product to Stericycle using the label provided with the letter and if they have distributed the product further, notify their accounts that received the product . Please contact Hospira Customer Care at 1-877-946-7747 |
| Quantity | 5,817,600 syringes |
| Distribution | Nationwide distribution including states of: Alabama, Alaska, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, New York, No |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090882 | FLUSH SYRINGE FILLED WITH 0.9% SODIUM CHLORIDE Hospira, Inc., Apr 23, 2010 |