Ventralight ST 4.5" Circle with Echo PS- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955450
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: (01)00801741031724(17)240428(10) Lot Numbers: Lot Number HUGS0922 HUGS2026 HUGS2061 HUGS2020 HUGS2044 HUGS2015 HUGS2076 HUGT1582 HUGU0750 HUGU0748
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Davol, Inc.
- Reason for Recall:
- Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Ventralight ST 4.5" Circle with Echo PS- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955450
Product Codes/Lot Numbers:
UDI-DI: (01)00801741031724(17)240428(10) Lot Numbers: Lot Number HUGS0922 HUGS2026 HUGS2061 HUGS2020 HUGS2044 HUGS2015 HUGS2076 HUGT1582 HUGU0750 HUGU0748
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2242-2023
Related Recalls
Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.
Davol
Potential for product to contain foreign matter, confirmed to be inspect fragments.
Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection
Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection