The Recall Desk

FDA (Devices) recall action 76476

LeMaitre Vascular, Inc. recalled 12 products on 2017-03-22

The FDA (Devices) publishes a recall like this one as 12 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 12 pages.

Products
12
Announced
2017-03-22
Critical
0
Units
21,150

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–12 of 12

  • ModerateFDA (Devices)··2017-03-22

    LeMaitre Vascular Catheter Recalled for Missing Latex Warning Symbol

    LeMaitre Vascular is recalling 46 units of Reddick Scoop Tip Cholangiogram Stiffer Catheters because the latex warning symbol was missing from the packaging.

    Product
    LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter with Introducer (paper IFU) REF# 2401-53
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2017-03-22

    LeMaitre Vascular Cholangiogram Catheter Recalled for Missing Latex Labeling

    LeMaitre Vascular is recalling 250 units of Reddick Cholangiogram Stiffer Catheters because the latex warning symbol was not printed on the packaging.

    Product
    LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (eIFU) REF # e2400-53
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2017-03-22

    LeMaitre Vascular Catheter Recalled for Missing Latex Warning Symbol

    LeMaitre Vascular is recalling Reddick Scoop Tip Cholangiogram Stiffer Catheters because the latex warning symbol was missing from the packaging.

    Product
    LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter (paper IFU) REF# 2401-50
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2017-03-22

    LeMaitre Vascular Cholangiogram Catheter Recalled for Missing Latex Symbol

    LeMaitre Vascular is recalling 247 units of Scoop Tip Cholangiogram Catheters because the latex warning symbol was missing from the packaging.

    Product
    LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (paper IFU) REF# 2401-52
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2017-03-22

    LeMaitre Vascular Cholangiogram Catheter Recalled for Missing Latex Symbol

    LeMaitre Vascular is recalling Reddick Scoop Tip Cholangiogram Catheters because the latex symbol was not printed on the packaging.

    Product
    LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-51
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2017-03-22

    LeMaitre Vascular Catheter Recalled for Missing Latex Warning Label

    LeMaitre Vascular is recalling Reddick Cholangiogram Stiffer Catheters because the latex warning symbol was missing from the packaging.

    Product
    LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (paper IFU) REF# 2401-51
    Category
    Distribution
    0 states