Recall Z-2720-2017 ยท FMG Stopcock, I.V. Set
ICU Medical, Inc.
PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave (Red Rings), Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein)..
| Date | Jun 26, 2017 (initiated May 30, 2017) |
| Status | Terminated |
| Reason | The connection between the Female Luer and the NanoClave manifold has the potential for developing a leak. |
| Root cause | Nonconforming Material/Component |
| Action | Customers were notified via letter on approximately 05/30/2017 and were instructed to examine their inventory, quarantine affected products, complete and return the response form, and return to ICU Medical. If there are any questions or assistance needed, customers can call ICU Customer Service Monday through Friday between 8:30 AM and 4:00 PM Pacific time: 866-829-9025. Or they can email: Productreturns@icumed.com. |
| Quantity | 70 units |
| Distribution | Distribution to Italy and France, and the following states in the US: AZ, OH, TX, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964435 | PRIMARY IV SET Icu Medical, Inc., Apr 2, 1997 |