CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (La ...



CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single pack); 2. CanGaroo Envelope (Medium) (single pack); 3. CanGaroo Envelope (Extra Large) (single pack); 4. CanGaroo Envelope (Extra Extra Large) (single pack); 5. CanGaroo Envelope (Large) (5 pack); 6. CanGaroo Envelope (Medium) (5 pack); 7. CanGaroo Envelope (Extra Large) (5 pack); 8. CanGaroo Envelope (Extra Extra Large) (5 pack) Product Usage: The CanGaroo Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.
Components:
Recall Date:    Aug 21, 2019
Mfg:
AZIYO BIOLOGICS
Mfg Country:
United States
Recall ID:    83652
Product ID:    176027
Enforcement Date:    Oct 16, 2019
Termination Date:    Sep 17, 2020
Last Published:    Sep 17, 2020

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Emert Number:    Z-0040-2020
Emert Status:    Terminated