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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. LOT Number 4330832. Product not distributed in US, UDI: 1 0840619 04197 4

FDA Recall Z-1996-2020 · Posted None

Recalling FirmICU Medical, Inc.
Recall StatusTerminated
Product CodeDQE
Date Initiated2020-01-02
Date Terminated2022-09-14
Product Quantity20

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.

Official Source

View FDA Recall →

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

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