Reported Oct 16, 2019 · Terminated
BioEnvelope, surgical mesh envelope. 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?
BioEnvelope, surgical mesh envelope. Labeled as the following
8 of 8 products
| # | Product as published |
|---|---|
| 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. |
- Lot codes and dates
8 of 8 products
Products covered by this recall Model / number Product as published 440576(UDI Number 004035479160524) Lot Numbers: M18A1010, M18A1022, M18C1070, M18G1185 440577(UDI Number 004035479160531) Lot Number M18A1021 440578(UDI Number 004035479160548) Lot Numbers: M18A1008, M18B1051, M18G1181 440579(UDI Number 004035479160555) Lot Numbers: M18F1146, M18G1188 440622(UDI Number 004035479160616) Lot Numbers: M18A1007, M18D1080 440623(UDI Number 004035479160623) Lot Numbers: M18A1015, M18C1071 440625(UDI Number 004035479160647) Lot Number M18G1189 440626(UDI Number 004035479160654) Lot Numbers: M18A1014; M18B1054 - Amount recalled
- 1018 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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