Reported Oct 3, 2018 · Terminated
Medtronic Clip Gun Magazines are packaged in individually sealed pouches and distributed in boxes containing 5…
Medtronic Neurosurgery
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Neurosurgery · 125 Cremona Dr · Goleta, CA · 93117-3083
Is this the product you have?
- 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
- Lot codes and dates
- Product Number/CFNCM8902
- UDI-Device Identifier (GTIN/UPN)20643169647200
- Lot Numbers
54984571885955866312and 67988
- Amount recalled
- 2616
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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