Medtronic Clip Gun Magazines Recalled for Packaging Sterility Defect
Medtronic Neurosurgery is recalling Clip Gun Magazines because the packaging sterile barrier may be compromised without visible signs.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile medical device) where a packaging defect could compromise sterility, but no injuries or illnesses have been reported.
Plain-English summary
Medtronic Neurosurgery is recalling 2,616 units of Medtronic Clip Gun Magazines (REF CM8902). The recall involves specific lot numbers: 54984, 57188, 59558, 66312, and 67988. The devices are sterile, single-use, and distributed in boxes containing five individually pouched magazines.
The recall was initiated because the packaging sterile barrier does not comply with the applicable packaging standard for terminally sterilized medical devices. Although the Instructions for Use state "Do not use if package has been previously opened or damaged," the source text notes that a seal breach may go undetected by the user's naked eye.
The affected products were distributed domestically in 37 states and the District of Columbia, as well as internationally in Australia, Germany, Kenya, the Russian Federation, and South Africa. Users should check their inventory for the specific lot numbers listed and contact Medtronic Neurosurgery for further instructions.
The recalled product
- 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
- Manufacturer
- Medtronic Neurosurgery
- Affected units
- 2,616
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 57188
- 59558
- 66312
- and 67988
Distribution
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