Recall Z-0622-2018
Medtronic Neurosurgery · initiated December 20, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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)
Codes / lots: Affected Lots: D80412, D84100, E00008, E00983, E03049, E03716, E05806, E07257, E09145, E14782, E14896, E15195, E19181, E19182, E19183, E19184, E19868, E20599, E23631, E33102, D80413, D84101, E00009, E00984, E03050, E03717, E05233, E05807, E07258, E09117, E09146, E09239, E11242, E11243, E11244, E11706, E12011, E12012, E13574, E14784, E14898, E15197, E19185, E19186, E19187, E19188, E19869, E20600, E23768, E23769, E23770, E23771, E23772, E23773, E23774, E33103, E33104, E33105, E33106, E33107, E33108, E33109, E33110, E33454, E34928, E05810, E09149, E19194, E19871, E23775, E33099
Reason for recall
Medtronic is initiating a voluntary recall because the products identified above did not adequately demonstrate acceptable packaging performance to current standards.
FDA-determined cause: Package design/selection
Action taken
A Consignee Notification with response form was sent to affected consignees on 12/20/2017.
Details
- Recall number
- Z-0622-2018
- Initiated
- December 20, 2017
- Terminated
- December 8, 2023
- Product code
- HBO – Clip, Scalp
- 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, USA, Yemen
- Recalling firm
- Medtronic Neurosurgery, Goleta, CA