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MEDTRONIC PS MEDICAL, INC. · Model CG8900 · UDI-DI 00643169647176
HBO
Prescription
1
510(k) clearances
68
Adverse events
3
Recalls
31
Facilities
Description
GUN CG8900 RANEY CLIP KIT 1PK
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-06-01 | Integra LifeSciences Corp. | Packaging-pouches with wrinkles across the Tyvek side may compromise the integrity of the pouch's sterile barrier |
| 2018-05-03 | Medtronic Neurosurgery | 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 |
| 2017-12-20 | Medtronic Neurosurgery | Medtronic is initiating a voluntary recall because the products identified above did not adequately demonstrate acceptable packaging performance to current standards. |
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