FDA (Devices) recall action 79195
The FDA (Devices) publishes a recall like this one as 20 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 20 pages.
Label does not state that the product is heparin-coated.
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.
Cook Inc. is recalling 601,778 Fixed Core Wire Guides because the labels failed to state that the products are heparin-coated.
Cook Inc. is recalling 3,369 Coons Interventional Wire Guides because the label fails to state that the product is heparin-coated.
Cook Inc. is recalling 56 Left Atrial Catheter Sets because the labels failed to state that the product is heparin-coated.
Cook Inc. is recalling 648 Amplatz Extra Stiff Whisker Wire Guides because the labels fail to state that the product is heparin-coated.
Cook Inc. is recalling 2,210 Fixed Core Bentson devices because the labels fail to state that the product is heparin-coated.
Cook Inc. is recalling 266 femoral artery pressure monitoring sets because the labels fail to state that the product is heparin-coated.
Cook Inc. is recalling Newton Wire Guides because the labels do not state that the product is heparin-coated.
Cook Inc. is recalling 45 Bentson Cerebral Wire Guides because the labels fail to state that the product is heparin-coated.
Cook Inc. is recalling Rosen Curved Wire Guides because the labels fail to state that the product is heparin-coated.
Cook Inc. is recalling 32,340 Amplatz Stiff Wire Guides because the labels fail to state that the product is heparin-coated.
Cook Inc. is recalling 18,398 units of Disposable Reuter Tip Deflecting Wire Guides because the labels fail to state that the product is heparin-coated.
Cook Inc. is recalling 10,367 Double Flexible Tipped Wire Guides because the labels fail to state that the product is heparin-coated.
Cook Inc. is recalling 55 Reuter Tip Deflecting Wire Guides because the labels fail to state that the product is heparin-coated.
Cook Inc. is recalling Bentson Wire Guides because the labels fail to state that the product is heparin-coated.
Cook Inc. is recalling 21,913 Movable Core Wire Guides because the labels failed to state that the products are heparin-coated.
Cook Inc. is recalling the Bentson Plus Wire Guide because the label fails to state that the product is heparin-coated.
Cook Inc. is recalling 13 Central Venous Catheter Trays because the label fails to state that the product is heparin-coated.
Cook Inc. is recalling 3,364 units of TFE Coated Curved Newton LLT because the label fails to state that the product is heparin-coated.
Cook Inc. is recalling 129,727 Amplatz Extra Stiff Wire Guides because the label fails to state that the product is heparin-coated.
Cook Inc. is recalling 12,462 Amplatz Ultra Stiff Wire Guides because the label fails to state that the product is heparin-coated.