Medtronic Neurosurgery: Medtronic Clip Gun Magazines are packaged in individually sealed pouches and distributed in boxes containing 5 individually pouched Clip Gun Magazine. REF CM8902, Medtronic Cli

Is my product affected?

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

• UPC 20643169647200

Check against the official notice below — it lists the full affected range.

What happened

Medtronic is recalling Clip Gun Magazines (Product Number CM8902) because the packaging sterile barrier does not comply with applicable packaging standards for terminally sterilized medical devices. Although the Instructions for Use state not to use packages that have been previously opened or damaged, seal breaches may not be visible to the naked eye, potentially going undetected by users. The recall involves 2,616 units distributed across 40 U.S. states and five international locations, affecting lot numbers 54984, 57188, 59558, 66312, and 67988.

The record does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: 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 Quantity: 2616 Lot/code info: Product Number/CFN: CM8902 UDI-Device Identifier (GTIN/UPN): 20643169647200 Lot Numbers: 54984; 57188; 59558; 66312; and 67988

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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