FDA (Devices) recall action 64682
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.
The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
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.
Stryker Endoscopy is recalling reusable irrigator tips because the instructions listed incorrect pre-vacuum steam sterilization temperatures.
Stryker Endoscopy is recalling reusable irrigator tips because the instructions for use listed incorrect pre-vacuum steam sterilization temperatures.
Stryker Endoscopy is recalling reusable irrigator tips because the instructions listed incorrect pre-vacuum steam sterilization temperatures.
Stryker Endoscopy is recalling reusable irrigator tips because the instructions for use listed incorrect pre-vacuum steam sterilization temperatures.
Stryker Endoscopy is recalling reusable irrigator tips because the instructions listed the wrong pre-vacuum steam sterilization temperature.
Stryker Endoscopy is recalling reusable irrigator tips because the instructions listed an incorrect pre-vacuum steam sterilization temperature.
Stryker Endoscopy is recalling 147,921 irrigator tips because the instructions for use listed incorrect pre-vacuum steam sterilization temperatures.
Stryker Endoscopy is recalling reusable irrigator tips because the instructions for use listed incorrect pre-vacuum steam sterilization temperatures.
Stryker Endoscopy is recalling reusable irrigator tips because the instructions listed incorrect pre-vacuum steam sterilization temperatures.
Stryker Endoscopy is recalling reusable irrigator tips because the instructions for use listed incorrect pre-vacuum steam sterilization temperatures.
Stryker Endoscopy is recalling reusable irrigator tips because the instructions listed incorrect pre-vacuum steam sterilization temperatures.
Stryker Endoscopy is recalling 147,921 irrigator tips because the instructions listed incorrect pre-vacuum steam sterilization temperatures.
Stryker Endoscopy is recalling reusable irrigator tips because the instructions listed incorrect pre-vacuum steam sterilization temperatures.
Stryker Endoscopy is recalling reusable irrigator tips because the instructions for use listed incorrect pre-vacuum steam sterilization temperatures.
Stryker Endoscopy is recalling reusable irrigator tips because the instructions listed incorrect pre-vacuum steam sterilization temperatures.
Stryker Endoscopy is recalling reusable irrigator tips because the instructions listed incorrect pre-vacuum steam sterilization temperatures.
Stryker Endoscopy is recalling 147,921 irrigator tips because the instructions listed incorrect pre-vacuum steam sterilization temperatures.
Stryker Endoscopy is recalling reusable irrigator tips because the instructions listed incorrect pre-vacuum steam sterilization temperatures.
Stryker Endoscopy is recalling 147,921 reusable irrigator tips because the instructions for use listed incorrect pre-vacuum steam sterilization temperatures.
Stryker Endoscopy is recalling reusable irrigator tips because the instructions listed incorrect pre-vacuum steam sterilization temperatures.