Known Identifiers & Locations
FEI Numbers
3005619880
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (0)
No 510(k) notifications found for this entity.
FDA Recall History (2)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0039-2020 |
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.
Reason: Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device.
|
2019-08-21 |
Terminated
|
View Details
|
| Z-0040-2020 |
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.
Reason: Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device.
|
2019-08-21 |
Terminated
|
View Details
|
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