Medtronic Neurosurgery recalls Medtronic Clip Gun Magazines are packaged in individually sealed pouches and distributed in boxes containing 5 individu…

Recall date

May 3, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3212-2018

FDA classification

Class II

Brand / firm

Medtronic Neurosurgery

Sold / distributed

Domestic: AL, AZ, AR, CA, CO, DC, FL, GA, ID, IL, IN, IA, KS, LA, MD, MI, MN, MS, MO, NB, NV, NJ, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI, and WY OUS: Australia, Germany, Kenya, Russian Federation, South Africa

Why it was recalled

The packaging sterile barrier does not comply with the applicable packaging standard for terminally sterilized medical devices. While the Instructions for Use (IFU) state Do not use if package has been previously opened or damaged , it is possible that the seal breach may go undetected by the user's naked eye.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Medtronic Clip Gun Magazines are packaged in individually sealed pouches and distributed in boxes containing 5 individually pouched Clip Gun Magazine. REF CM8902, Medtronic Clip Gun Magazine, Rx only, CE 0344, STERILE EO, Rx only, Single Use