Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.

Recall Insight

This FDA Devices action (record #Z-3196-2018) was formally reported on September 26, 2018, with the manufacturer initiating the action on July 13, 2018. It is classified under Low severity (Class III), with a current status of Terminated. Smiths Medical ASD Inc. is listed as the recalling firm, operating out of Minneapolis, MN. Federal records indicate 29,600 kits units are affected.

The documented reason for this recall is: The product was mislabeled with the incorrect label. Distribution data in the federal record shows the product reached: US Nationwide Distribution in the states of CT, MA, MI, NC, NJ, NY, RI, TX, UT, and WA.. 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 8 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.