FDA recall Z-0622-2018

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)

Reason for recall

Medtronic is initiating a voluntary recall because the products identified above did not adequately demonstrate acceptable packaging performance to current standards.

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

Key facts

Status

Terminated

Initiation date

2017-12-20

Report date

2018-02-21

Termination date

2023-12-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Goleta, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0622-2018