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 # 41401-25.
FDA Recall Z-1998-2020 · Posted None
Recalling FirmICU Medical, Inc.
Recall StatusTerminated
Product CodeDQE
Date Initiated2020-01-02
Date Terminated2022-09-14
Product Quantity10
Reason for Recall
Inability for the guidewire to pass through the needles included with the catheter kits.
Firm 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.
Root Cause
Process control
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.