BioEnvelope, surgical mesh envelope. Labeled as the following: 1. Bi ...



BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single pack); 2. BioEnvelope (Large) (single pack); 3. BioEnvelope (Extra Large) (single pack); 4. BioEnvelope (Extra Extra Large) (single pack); 5. BioEnvelope (Large) (5-pack); 6. BioEnvelope (Medium) (5-pack); 7. BioEnvelope (Extra Extra Large) (5-pack); 8. BioEnvelope (Extra Large) (5-pack) Product Usage: The BioEnvelope is intended to securely hold a cardiac implantable electronic device 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.
Components:
Recall Date:    Aug 21, 2019
Mfg:
AZIYO BIOLOGICS
Mfg Country:
United States
Recall ID:    83652
Product ID:    176026
Enforcement Date:    Oct 16, 2019
Termination Date:    Sep 17, 2020
Last Published:    Sep 17, 2020

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Emert Number:    Z-0039-2020
Emert Status:    Terminated