FDAClass IIMarch 22, 2017

LeMaitre Vascular Reddick Cholangiogram Catheter recall

LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50

Why was LeMaitre Vascular Reddick Cholangiogram Catheter recalled?

The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch

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 Number/Exp. Date: RED1743 2018-09 RED1744 2018-09 RED1749 2018-10 RED1750 2018-12 RED1751 2018-12 RED1755 2018-12 RED1756 2018-12 RED1757 2019-01 RED1759 2019-02 RED1760 2019-02 RED1761 2019-03 RED1764 2019-03 RED1766 2019-04 RED1767 2019-04 RED1768 2019-05 RED1769 2019-05 RED1771 2019-06 RED1773 2019-07 RED1774 2019-07 RED1775 2019-07

Product
LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50
Recalling firm
LeMaitre Vascular, Inc.
Quantity
5601
Distribution
Worldwide distribution. US Nationwide, AUSTRIA, BELGIUM, FRANCE, GERMANY, ITALY, LUXEMBOURG, Morocco, Saudi Arabia, Singapore, SPAIN, SWITZERLAND, UAE, and UK
Recall date
March 22, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls