—#180687

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. Model # 41401-25.

FDA product code: DQE — Catheter, Oximeter, Fiber-Optic
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K091268
Affected lot / code info: LOT Number/ UDI-4156005/1 0840619 04410 4

Why it was recalled

Inability for the guidewire to pass through the needles included with the catheter kits.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: ICU Medical, Inc.
Address: 951 Calle, Amanecer San Clemente, California 92673-6212

Distribution

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.

Timeline

Recall initiated: 2020-01-02
Terminated: 2022-09-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #180687. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.