Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079.

Recall Insight

This FDA Devices action (record #Z-1829-2017) was formally reported on April 26, 2017, with the manufacturer initiating the action on March 29, 2017. It is classified under Low severity (Class III), with a current status of Terminated. Teleflex Medical is listed as the recalling firm, operating out of Research Triangle Park, NC. Federal records indicate 4760 eaches units are affected.

The documented reason for this recall is: Some of the individual unit packaging (pouches) may be missing the lot number an expiration date. Distribution data in the federal record shows the product reached: AL, AK, AZ AR, CA, CO, CT, FL, GA, HI, ID, IL IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, Canada and Costa Rica. 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 9 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.