FDA Device recall Z-1996-2020
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-1996-2020 |
| 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. LOT Number 4330832. Product not distributed in US, UDI: 1 0840619 04197 4
Reason
Inability for the guidewire to pass through the needles included with the catheter kits.
Identifiers
| code_info | LOT 4330832 UDI:1 0840619 04197 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-1996-2020%22
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