ICU Medical, Inc. Recall 86973
Description: 60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave¿ Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
ICU Medical, Inc. Recall 86973 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0956-2021 |
| Event ID | 86973 |
| Event Description | 60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave¿ Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein). |
| Product Type | Devices |
| Distribution | Worldwide distribution - U.S. Nationwide distribution including in the states of AZ, CA, CO, CT, FL, ID, IL, LA, MA, MN, NC, NJ, NY, TN, TX, VA, WA and WV. The country of Belgium. |
| Quantity | Total Kits = 7,500 for all four lots |
| Recall Reason | Due to the incorrect filter assembly. |
| Device Classification | 20210217 |
| Device Code Info | Model List Number: MC330174 UDI: (01)10887709079974(17)250401(30)50(10)4799374 Lot Number: 4799374 |
| Center Classification Date | 20210205 |
| Recall Initiation Date | 20201202 |
| Recalling Firm | ICU Medical, Inc. |
| Initial Notification | Letter |
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