Recall Z-2948-2018 ยท NGT Saline, Vascular Access Flush
Medline Industries Inc
Medline 0.9 % Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR Intended for flushing IV catheters and IV tubing only.
| Date | Feb 1, 2018 |
| Status | Terminated |
| Reason | Packaged with an incorrect overwrap. |
| Root cause | Employee error |
| Action | The firm, Medline Industries, Inc., sent an "URGENT RECALL IMMEDIATE ACTION REQUIRED" letter dated February 1, 2018 to their consignees with the required actions to be followed; 1. Immediately check your stock for item number EMZ10051240 and the affected lot number, 3131591, and quarantine all affected product. 2. Please return the completed enclosed destruction form listing the quantity of affected product on hand. Even if you do not have any affected product please complete and return the form, as indicated on the destruction form. When we receive your completed destruction form your accoun |
| Quantity | 90,870 units |
| Distribution | US Nationwide Distribution to states of: CA, CT, DE, FL, GA, IN, LA, MA, MD, MN, MS, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, VT, WA and WV |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142620 | 0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10 mL Syringe, Excelsior Medical Corporation, Dec 12, 2014 |