Reported Oct 16, 2019 · Terminated
CanGaroo Envelopes labeled as the following
Aziyo Biologics
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: AZIYO BIOLOGICS · 1100 Old Ellis Rd · Roswell, GA · 30076-4992
Is this the product you have?
CanGaroo Envelopes labeled as the following
8 of 8 products
| # | Product as published |
|---|---|
| 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. |
- Lot codes and dates
8 of 8 products
Products covered by this recall Model / number Product as published CMCV-009-LRG(UDI Number 000859389005065) Lot Numbers: M18B1053, M18D1080, M18D1081, M18D1091, M18D1095, M19B1077, M19C1083, M19D1144, M19D1148 CMCV-009-MED(UDI Number 000859389005034) Lot Numbers: M18C1071, M18D1088 CMCV-009-XLG(UDI Number 000859389005072) Lot Numbers: M18B1051, M18B1052, M18B1054, M18C1068, M18C1069, M19D1160, M19D1163 CMCV-009-XXL(UDI Number 000859389005119) Lot Numbers: M18D1094, M19C1101, M19C1123 CMCV-010-LRG(UDI Number 010859389005062) Lot Numbers: M18A1007, M18M1303, M18N1330, M19B1071, M19C1104, M19C1119 CMCV-010-MED(UDI Number 010859389005031) Lot Number M18A1015 CMCV-010-XLG(UDI Number 010859389005079) Lot Numbers: M18F1160, M18F1161 CMCV-010-XXL(UDI Number 010859389005116) Lot Number M18F1159 - Amount recalled
- 2693 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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