FDAClass IIMarch 22, 2017

LeMaitre Vascular Reddick Cholangiogram Stiffer recall

LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (eIFU) REF # e2400-53

Why was LeMaitre Vascular Reddick Cholangiogram Stiffer 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/Ex p. Date: RED1747 2018-09 RED1754 2018-12 RED1763 2019-03 RED1770 2019-05

Product
LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (eIFU) REF # e2400-53
Recalling firm
LeMaitre Vascular, Inc.
Quantity
250
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