FDAClass IIApril 4, 2018

HEMASHIELD Knitted Double Velour Cardiovascular Fabric recall: Labeling Error

HEMASHIELD Knitted Double Velour Cardiovascular Fabric

Why was HEMASHIELD Knitted Double Velour Cardiovascular Fabric recalled?

A probable mislabeling of the product: a different-sized product is referenced on the product packaging label (i.e. 2.5 cm (width) x 7.6 cm (length)) while the actual product inside the box is 2.5 cm (width) x 15 cm (length).

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 code: 00384401017899 Catalog number: M002000195140 Lot number: 16M21 Serial number: 1092238229

Product
HEMASHIELD Knitted Double Velour Cardiovascular Fabric
Recalling firm
GETINGE US SALES LLC
Quantity
1
Distribution
FL
Recall date
April 4, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls