Recall Z-1444-2017— LeMaitre Vascular, Inc.

Class II · Terminated

Class II FDA medical device recall by LeMaitre Vascular, Inc., initiated 2017-02-07, terminated 2019-09-20. FDA's recall record names no specific 510(k) clearance for this event. Product: LeMaitre Vascular Reddick Cholangiogram Catheter with introducer(eIFU) REF # e2400-52. Reason: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch.

Recalling firm
LeMaitre Vascular, Inc.
Classification
Class II
Status
Terminated
Initiated
2017-02-07
Terminated
2019-09-20
Firm location
Burlington, MA, United States

Product description

LeMaitre Vascular Reddick Cholangiogram Catheter with introducer(eIFU) REF # e2400-52

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.