The HEMASHIELD PLATINUM Woven Double Velour Vascular recall
The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double velour polyester graft impregnated with highly purified bovine collagen.…
Why was The HEMASHIELD PLATINUM Woven Double Velour Vascular recalled?
Based on an internal incident report, Getinge/Intervascular SAS has identified that the one (1) HEMASHIELD GOLD Knitted Microvel Double Velour Vascular Bifurcated Graft product with the diameter size of 16 x 9 mm is likely incorrectly packed inside of the carton which was labeled to contain a HEMASHIELD PLATINUM Woven Double Velour Vascular Graft product with the diameter size of 16 x 8 mm ((REF: M00202166168P0, Lot: 18K31, SN: 1190443415, size 16 x 8 mm).
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?
Lot Code: 18K31 Serial Number: 1190443415 Part Number: M00202166168P0 UDI Code: 00384401018452
- Product
- The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double velour polyester graft impregnated with highly purified bovine collagen.…
- Recalling firm
- GETINGE US SALES LLC
- Quantity
- 1 unit
- Distribution
- US state of NJ
- Recall date
- October 2, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)