FDA Device recall Z-3212-2018
Medtronic Clip Gun Magazines are packaged in individually sealed pouches and distributed in boxes containing 5 individually pouched Clip Gu…
- FDA Device
- Class II
- terminated
- Published 2018-10-03
On 2018-10-03 the FDA classified a Class II recall of Medtronic Clip Gun Magazines are packaged in individually sealed pouches and distributed in boxes containing 5 individually pouched Clip Gu… by Medtronic Neurosurgery, citing 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 u….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3212-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-03 |
| Published | 2018-10-03 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic Neurosurgery |
| Distribution | AL, AR, AZ, CA, CO, DC, FL, GA, IA, ID, IL, IN, KS, LA, MD, MI, MN, MO, MS, NC, ND, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY |
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.
Identifiers
| code_info | Product Number/CFN: CM8902 UDI-Device Identifier (GTIN/UPN): 20643169647200 Lot Numbers: 54984; 57188; 59558; 66312; and 67988 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Medtronic Neurosurgery
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FDA Device · Class II · 2026-07-29 · Medtronic Neurosurgery - Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM 27636 EDM 27636 EXACTA W/BRAIDED CORD LOCK 27666 ED…
FDA Device · Class I · 2024-12-25 · Medtronic Neurosurgery - Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SITE 25120 EDMS II 25120 BECKER W/1-WAY VALVE 26040 KIT 26040…
FDA Device · Class I · 2024-12-25 · Medtronic Neurosurgery - Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, Sterile EO, Rx Only
FDA Device · Class I · 2024-03-06 · Medtronic Neurosurgery - Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, Sterile EO, Rx Only
FDA Device · Class I · 2024-03-06 · Medtronic Neurosurgery
All Medtronic Neurosurgery recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3212-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.