Recall Z-1095-2019 ยท FPA Set, Administration, Intravascular
ICU Medical, Inc.
icumedical Oncology Kit w/12" (30cm) Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented Vial Spike, 20mm; ChemoClave Vented Vial Spike, 13mm; Spiros wRed Cap, REF 3944. Used in IV administration sets. The ChemoCLAVE Cytotoxic Medication Preparation and Delivery System consists of 6 previously cleared components (CLAVE, Spikes, SPIROS, GENIE, Vial Access, and Admin Sets) that
| Date | Apr 15, 2019 (initiated Feb 21, 2019) |
| Status | Terminated |
| Reason | There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device. |
| Root cause | Vendor change control |
| Action | The firm, Icumedical, initiated the recall by "URGENT: MEDICAL DEVICE RECALL" letter on 02/21/2019 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1) Please discontinue the use and distribution of the affected product immediately. Check your inventory and quarantine all affected product at your facility. 2) Inform potential users of the product in your organization of this notification and complete the attached response form via fax to: 1-855-497-9856 or email to: ICUMedical6834@stericycle.com, even if y |
| Quantity | 300 devices |
| Distribution | Worldwide distribution: US nationwide and countries of: Canada, France, and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.