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

Recall Insight

This FDA Devices action (record #Z-1996-2020) was formally reported on May 20, 2020, with the manufacturer initiating the action on January 2, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. ICU Medical, Inc. is listed as the recalling firm, operating out of San Clemente, CA. Federal records indicate 20 units are affected.

The documented reason for this recall is: Inability for the guidewire to pass through the needles included with the catheter kits. Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 6 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.