Central Venous Catheters are indicated for the assessment of… — Class II medical device recall Z-1996-2020
Terminated recall by ICU Medical, Inc., reported 2020-05-20, distributed in AL, CA, FL, GA, IL, ME, MI, MN…. Inability for the guidewire to pass through the needles included with the catheter kits.
| Recall number | Z-1996-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical, Inc., San Clemente, CA, United States |
| Recall initiated | 2020-01-02 |
| Classified | 2020-05-14 |
| Reported by FDA | 2020-05-20 |
| Terminated | 2022-09-14 |
| Distributed | AL, CA, FL, GA, IL, ME, MI, MN, MS, NC, NH, NM, NY, OH, TX, UT, VA, WA |
| Countries outside the US | CA |
| Quantity | 20 |
| Lot numbers | 4330832 |
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 for recall
Inability for the guidewire to pass through the needles included with the catheter kits.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1996-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.