Medtronic recalls Clip Gun Magazines with potentially undetected packaging seal breaches that could compromise sterility during surgery. Affected units have specific lot numbers and are sold in sealed pouches.
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.
Medtronic is recalling Clip Gun Magazines that may have packaging seals that don't show damage to the user's naked eye. This could mean the medical device isn't sterile when used, which is dangerous during surgery.
The packaging seal for these sterile medical devices might be broken without the user noticing. If the seal is broken, the device could become contaminated and not be sterile when used during surgery.
Surgical professionals and hospitals that use these Clip Gun Magazines for neurosurgery procedures. The risk is highest for those using the product without checking the packaging seal.
Check for lot numbers 54984, 57188, 59558, 66312, or 67988 on the packaging. These Clip Gun Magazines come in sealed pouches inside boxes containing five units.
Inspect the pouch for any visible damage or breaches before use.
The packaging seal may not show damage to the naked eye, which could mean the device isn't sterile when used during surgery.
Look for lot numbers 54984, 57188, 59558, 66312, or 67988 on the packaging of the Clip Gun Magazines.
The recall does not require immediate action, but you should check the packaging seal before use to ensure sterility.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-3212-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-3212-2018 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
