FDA (Devices) recall action 98495
The FDA (Devices) publishes a recall like this one as 18 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 18 pages.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
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 Medical is recalling Thal-Quick Chest Tube Trays because affected lots were labeled with expiration dates that exceed the product's true shelf life. Two units are affected.
Cook Medical is recalling Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Sets because affected lots were labeled with expiration dates that exceed the true shelf life. 484 units are affected.
Cook Medical is recalling Approach CTO-18 Micro Wire Guides because affected lots were labeled with expiration dates that exceed the product's true shelf life. 75 units are affected.
Cook Medical is recalling Wayne Pneumothorax Trays because affected lots were labeled with expiration dates that exceed the product's true shelf life. 318 units are affected.
Cook Medical is recalling custom Spectrum Central Venous Catheter Trays because affected lots were labeled with expiration dates that exceed the true shelf life. 1,872 units are affected.
Cook Medical is recalling a Multipurpose Drainage Catheter because affected lots were labeled with expiration dates that exceed the product's true shelf life. 20 units are affected.
Cook Medical is recalling Staged Extubation Sets because affected lots were labeled with expiration dates that exceed the product's true shelf life. 95 units are affected.
Cook Medical is recalling Approach CTO-12 Micro Wire Guides because affected lots were labeled with expiration dates that exceed the product's true shelf life. 49 units are affected.
Cook Medical is recalling Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Sets because affected lots were labeled with expiration dates that exceed the true shelf life. 916 units are affected.
Cook Medical is recalling the Strange Bile Duct Stone Exploration Set because affected lots were labeled with expiration dates that exceed the product's true shelf life. 49 units are affected.
Cook Incorporated is recalling Melker Universal Cuffed Emergency Cricothyrotomy Catheter Sets because affected lots were labeled with expiration dates that exceed the true shelf life.
Cook Medical is recalling Wayne Pneumothorax Sets because affected lots were labeled with expiration dates that exceed the product's true shelf life. 104 units are affected.
Cook Medical is recalling Spectrum Central Venous Trays because affected lots were labeled with expiration dates that exceed the product's true shelf life. 2,348 units are affected.
Cook Medical is recalling Arterial Pressure Monitoring Trays because affected lots were labeled with expiration dates that exceed the product's true shelf life. 20 units are affected.
Cook Incorporated is recalling specific lots of COOK MEDICAL Approach CTO-6 Micro Wire Guides because they were labeled with expiration dates that exceed their actual shelf life.
Cook Medical is recalling Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Trays because affected lots were labeled with expiration dates that exceed the true shelf life. 441 units are affected.
Cook Medical is recalling Spectrum Central Venous Catheter Sets because affected lots were labeled with expiration dates that exceed the product's true shelf life. 5,080 units are affected.
Cook Medical is recalling NCompass Nitinol Stone Extractors because affected lots were labeled with expiration dates that exceed the product's true shelf life. 70 units are affected.