Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) Catheter Product Usage: The multiple-lumen catheter permits venous access to central circulation.

Recall Insight

This FDA Devices action (record #Z-1830-2012) was formally reported on July 4, 2012, with the manufacturer initiating the action on May 3, 2012. It is classified under Critical severity (Class I), with a current status of Terminated. Arrow International Inc is listed as the recalling firm, operating out of Reading, PA. Federal records indicate 634,912 units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: Lidstock of product does not contain chlorhexidine contraindication and contains wording "contains no medication" on the label. Product insert does reflect medicated status. Distribution data in the federal record shows the product reached: Worldwide Distribution - United States (nationwide) include the state of Texas. and the countries of: ARMENIA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELGIUM, CANADA, CHILE, COLOMBIA, COSTA RICA, CYPRUS, CZECH R…. 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 14 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.