Recall Z-0622-2018 ยท HBO Clip, Scalp
Medtronic Neurosurgery
Model #: CG8900, Medtronic Clip Gun Scalp Clip Kit (Qty 1); Model #: CG8901, Medtronic Clip Gun Scalp Clip Kit (Qty 10); Model #: CG8901A, Medtronic Clip Gun Applicator (Qty 10)
| Date | Dec 20, 2017 |
| Status | Terminated |
| Reason | Medtronic is initiating a voluntary recall because the products identified above did not adequately demonstrate acceptable packaging performance to current standards. |
| Root cause | Package design/selection |
| Action | A Consignee Notification with response form was sent to affected consignees on 12/20/2017. |
| Quantity | 27,432.8 devices |
| Distribution | Algeria, Armenia, Australia, Canada, Cyprus, Egypt, Germany, Ghana, Greece, Guam, Iceland, Indonesia, Iran, Italy, Jordan, New Zealand, Poland, Portugal, Puerto Rica, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Swaziland, Sweden, Switzerland, Syria, Tunisia, Turkey, UAE, UK, US |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050044 | MEDTRONIC CLIP GUN KIT Medtronic Neurosurgery, Feb 7, 2005 |