medical Class II Updated 2018-10-03

Medtronic Neurosurgery recalls Medtronic Clip Gun Magazines are packaged in individually se

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Affected States: AL, AZ, AR, CA, CO, DC, FL, GA, ID, IL, IN, IA, KS, LA, MD, MI, MN, MS, MO, NV, NJ, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI, WY

Lot/Code Info: Product Number/CFN: CM8902 UDI-Device Identifier (GTIN/UPN): 20643169647200 Lot Numbers: 54984; 57188; 59558; 66312; and 67988

View official government recall

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