Z-1999-2020 Class II Terminated
FDA device recall Z-1999-2020 was initiated by ICU Medical, Inc. on January 2, 2020 and is designated Class II. Reason for recall: Inability for the guidewire to pass through the needles included with the catheter kits. The recall status is terminated (terminated September 14, 2022). Affected quantity: 60.
Recall Details
- Product Type
- Devices
- Report Date
- May 20, 2020
- Initiation Date
- January 2, 2020
- Termination Date
- September 14, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60
Product 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 for Recall
Inability for the guidewire to pass through the needles included with the catheter kits.
Distribution Pattern
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.
Code Information
LOT Number/ UDI-4155999/1 0840619 04642 9, 4192320/1 0840619 04642 9