Recall Z-3212-2018— Medtronic Neurosurgery
Class II · Terminated
Class II FDA medical device recall by Medtronic Neurosurgery, initiated 2018-05-03, terminated 2022-08-30. It names one FDA 510(k) clearance: K050044. 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. Reason: 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..
- Recalling firm
- Medtronic Neurosurgery
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-05-03
- Terminated
- 2022-08-30
- Firm location
- Goleta, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.