FDAClass IIMay 13, 2020

HEMASHIELD PLATINUM Woven Double Velour Vascular Graft recall

HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175822P0 - 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: 1070624412 1072306151 1072300424 1123884494 1131457231 1131669419 1133302679 1151507540 1151511687 1152707813 1152559041 1152750757 1070621236 1070629009 1074513986 1074512017 1123911970 1131472773 1131605144 1152580776 1153707701

Product
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175822P0 - 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