Recall Z-0980-2017 ยท FMG Stopcock, I.V. Set
ICU Medical, Inc.
133" 60 Drop 24 Hour Primary Set w/2 Bravo24, 2 Gang 1o2 Manifold, Rotating Luer, 1 Ext, Item No. B59006 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). Each se
| Date | Jan 10, 2017 (initiated Nov 30, 2016) |
| Status | Terminated |
| Reason | ICU Medical Inc. has identified an isolated event involving a 15 drop drip chamber assembled on a device which should contain a 60 drop drip chamber. |
| Root cause | Mixed-up of materials/components |
| Action | An Urgent Medical Device Recall Notification letter dated 11/30/16 was sent to their customers to inform them that ICU Medical Inc. has identified an isolated event involving a 15 drop drip chamber assembled on a device which should contain a 60 drop drip chamber. The letter instructs the customers of the actions required and to return completed recall response form to ICU Medical via fax (801) 264-1755 or by email recall@icumed.com. Customers with questions are instructed to contact ICU Customer Service Monday through Friday between 8:30AM and 4PM Pacific Time, (866) 829-9025 and select opt |
| Quantity | 225 units |
| Distribution | US: NC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964435 | PRIMARY IV SET Icu Medical, Inc., Apr 2, 1997 |