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Z-2672-2014 Class II Terminated

Recalled by Vidacare Corporation — San Antonio, TX

FDA device recall Z-2672-2014 was initiated by Vidacare Corporation on March 31, 2014 and is designated Class II. Reason for recall: The voluntary recall is due to the needle set not meeting its specifications. The recall status is terminated (terminated January 30, 2015). Affected quantity: 172.

Recall Details

Product Type: Devices
Report Date: October 1, 2014
Initiation Date: March 31, 2014
Termination Date: January 30, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 172

Product Description

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

Reason for Recall

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

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

Code Information

Part number 9079-VC-005; lot code 3606455