The Recall Desk

FDA (Devices) recall action 75492

C.R. Bard, Inc. recalled 4 products on 2016-11-23

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2016-11-23
Critical
0
Units
300,356

Why these products were recalled

Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.

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.

1–4 of 4

  • ModerateFDA (Devices)··2016-11-23

    Bard Inlay Optima Ureteral Stent Recalled for Labeling Update

    C.R. Bard is recalling 75,089 Bard Inlay Optima ureteral stents to add a warning about potential knots during removal.

    Product
    Bard Inlay Optima¿ Multi-Length Ureteral Stent Coated Double Pigtail Ureteral Stent with Stent and Multi- Length Ureteral Stent with Suture, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-11-23

    Bard Fluoro-4 Silicone Ureteral Stent Recall for Labeling Update

    C.R. Bard is recalling 75,089 units of Bard Fluoro-4 Silicone Ureteral Stents to add a warning about potential knots during removal.

    Product
    Bard Fluoro-4 Silicone Ureteral Stent, Bard¿ Fluoro-4", Silicone Ureteral Coil Stent; Bard¿ Silicone Uretera l Coil Stent with Figure Four, End, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-11-23

    C.R. Bard Recalls Totalis Endo Kits for Labeling Update

    C.R. Bard is recalling 75,089 Totalis endo kits to add a warning about potential knots during removal.

    Product
    Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-11-23

    Bard Inlay Ureteral Stent Recalled for Labeling Update

    C.R. Bard is recalling 75,089 Bard Inlay Ureteral Stents to add a warning about potential knots during removal.

    Product
    BARD INLAY Ureteral Stent with Suture, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.
    Category
    Distribution
    0 states