Recall Z-2001-2020 ยท DQE Catheter, Oximeter, Fiber-Optic
ICU Medical, Inc.
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41414-23
| Date | Jan 2, 2020 |
| Status | Terminated |
| Reason | Inability for the guidewire to pass through the needles included with the catheter kits. |
| Root cause | Process control |
| Action | The firm has contracted Stericycle, Inc., Indianapolis, IN for customer notification, response tracking and effectiveness check. On 02 January 2020, Stericycle, Inc. sent URGENT: MEDICAL DEVICE RECALL notification of the market action to the firm's direct consignees of record. |
| Quantity | 235 |
| Distribution | US Consignees including in the states of AL, CA, FL, GA, IL, ME, MI, MN, MS, NC, NH, NM, NY, OH, TX, UT, VA and WA OUS - Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091268 | HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS Hospira, Inc., Sep 18, 2009 |