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Terminated

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 # 41411-25

FDA Recall Z-2000-2020 · 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.

K091268HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERSHospira, Inc. · 2009-09-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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