Recall Z-0523-2010 ยท KZD Infusor, Pressure, For I.V. Bags
Merit Medical Systems, Inc.
Merit Medical Sysems, Inc. Pressure Infusor Bag MERITMEDICAL 500 ml Pressure Infusor Bag CATALOG NUMBER PIB500 Used to apply pressure to a sealed bag of sterile fluid.
| Date | Dec 14, 2009 (initiated Sep 29, 2009) |
| Status | Terminated |
| Reason | Potential sterility breach caused by excessive shipment damage. |
| Root cause | Other |
| Action | Merit Medical Customers were contacted directly by phone and letter on 9/29/09. Customers were instructed to identify and quarantine all unused affected product. Further information was available at 801-208-4365. |
| Quantity | 24 Infusor bags |
| Distribution | US (AL, LA, MO, KY, TN, GA). No military, government or foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.