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Recall Observatory FDA recall evidence

Device product

EZ-IO 45mm (40kg & up) Needle Set, part number 9079-VC-005; lot code 3606455

Z-2672-2014

March 31, 2014

Class II

Product summary

Firm
Vidacare Corporation
Event
Event 67912
Status
Terminated
Classification
Class II
Quantity
172
Official record key
device-enforcement:Z-2672-2014

Official wording

Reason: The voluntary recall is due to the needle set not meeting its specifications.

Code information: Part number 9079-VC-005; lot code 3606455

Distribution pattern: Worldwide Distribution-US (nationwide) including the states of LA, NY, CA, CT, WA, AK, NJ, TX, GA, MI, MO, MD, FL, KY, VA, OH, UT, SC, NC, IN, AZ, MN, IL, TN, OK, KS, NE, MT, MS, AR, ID, WV and PA., and Internationally to Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The voluntary recall is due to the needle set not meeting its specifications.