BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 mm, Catalog #REF 362753, Lot #4063409 with expiry 03/2015, intended for the collection of whole blood and the separation of mononuclear cells.

Recall Insight

This FDA Devices action (record #Z-2542-2014) was formally reported on September 3, 2014, with the manufacturer initiating the action on July 3, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Becton Dickinson & Company is listed as the recalling firm, operating out of Franklin Lakes, NJ. Federal records indicate 296,160 tubes units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: BD has initiated the recall of its Vacutainer CPT Cell Preparation Tube due to poor separation, resulting in a reduced number of recovered mononuclear cells. Distribution data in the federal record shows the product reached: US and Foreign. 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 12 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.