BioEnvelope recall
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.
Why was BioEnvelope recalled?
Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
1. Catalog Number 440576 (UDI Number 004035479160524) Lot Numbers: M18A1010, M18A1022, M18C1070, M18G1185; 2. Catalog Number 440577 (UDI Number 004035479160531) Lot Number M18A1021; 3. Catalog Number 440578 (UDI Number 004035479160548) Lot Numbers: M18A1008, M18B1051, M18G1181; 4. Catalog Number 440579 (UDI Number 004035479160555) Lot Numbers: M18F1146, M18G1188; 5. Catalog Number 440622 (UDI Number 004035479160616) Lot Numbers: M18A1007, M18D1080; 6. Catalog Number 440623 (UDI Number 004035479160623) Lot Numbers: M18A1015, M18C1071; 7. Catalog Number 440625 (UDI Number 004035479160647) Lot Number M18G1189; 8. Catalog Number 440626 (UDI Number 004035479160654) Lot Numbers: M18A1014; M18B1054
- Product
- 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.
- Recalling firm
- AZIYO BIOLOGICS
- Quantity
- 1018 units
- Distribution
- US Nationwide distribution including the states of AL, AR, AZ, CA, FL, GA, HI, IL, IN, KS, KY, LA, LA, MI, MN, MO, MS, NC, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI.
- Recall date
- October 16, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)