FDA Device recall Z-2001-2020
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary arte…
- FDA Device
- Class II
- terminated
- Published 2020-05-20
On 2020-05-20 the FDA classified a Class II recall of Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary arte… by Icu Medical, citing inability for the guidewire to pass through the needles included with the catheter kits.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2001-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-02 |
| Published | 2020-05-20 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Icu Medical |
| Distribution | AL, CA, FL, GA, IL, ME, MI, MN, MS, NC, NH, NM, NY, OH, TX, UT, VA, WA |
Product
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
Reason
Inability for the guidewire to pass through the needles included with the catheter kits.
Identifiers
| code_info | LOT Number/ UDI - 4156000/1 0840619 04647 4, 4174850/1 0840619 04647 4, 4192313/1 0840619 04647 4, 4330831/1 0840619 04647 4, 4365303/1 0840619 04647 4 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2001-2020%22
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