INTERGARD Woven Vascular Graft is a woven polyester recall: Labeling Error
INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen. It has an external velour surface and non-velour inner…
Why was INTERGARD Woven Vascular Graft is a woven polyester recalled?
Mislabeled: Product labeled as Intergard Woven Straight graft REF IGW0032-30, D: 8 mm, L: 30 cm, contained an Intergard Woven Straight graft of D: 32 mm and L: 30 cm
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?
UDI: (01)00384401000280(11)201112(17)251031(21)1303435656GS(10)20L12; Lot number: 20L12 Serial number: 1303435656
- Product
- INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen. It has an external velour surface and non-velour inner…
- Recalling firm
- Maquet Cardiovascular, LLC
- Quantity
- 1 unit
- Distribution
- US Nationwide distribution in the state of SC.
- Recall date
- June 29, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)