FDAClass IIMay 13, 2020

HEMASHIELD PLATINUM Woven Double Velour Vascular Graft recall

HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Code: M00202175928P0 - Product Usage: for use in the replacement or repair…

Why was HEMASHIELD PLATINUM Woven Double Velour Vascular Graft recalled?

Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts

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?

Serial Numbers: 1136650764 1136649656 1138918524 1139377657 1143579436 1143599946 1147678079 1152754107 1158302730 1159727382 1159721538 1163859207 1166883762 1172730370 1177896586 1138937162 1141871928 1148785668 1152764001 1158785925 1159740547 1163841540 1168007426 1177892046

Product
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Code: M00202175928P0 - Product Usage: for use in the replacement or repair…
Recalling firm
Maquet Cardiovascular, LLC
Quantity
N/A
Distribution
Worldwide distribution - US Nationwide distribution and the countries of Dubai, Argentina, Austria, Belgium, Brazil, Japan, Canada, China, Germany, Spain, Finland, France, UK, Hongkong, Italy, Korea, Netherlands, Poland, Serbia, Sweden.
Recall date
May 13, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls