FDA Recall
Terminated
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 # 41406-23
Recall: Z-1999-2020
·
Initiated January 2, 2020
Recall
- Recall Number
- Z-1999-2020
- Event Number
- 85361
- Firm
- ICU Medical, Inc.
- FEI Number
- 2025816
- Product Code
- DQE
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- January 2, 2020
- Terminated
- September 14, 2022
- Address
- 951 Calle, Amanecer San Clemente, CA, 92673-6212
Description
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 # 41406-23
Reason
Inability for the guidewire to pass through the needles included with the catheter kits.
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.
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.
Quantity
60