FDA (Devices) recall action 84150
The FDA (Devices) publishes a recall like this one as 13 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 13 pages.
Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month 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.
Boston Scientific is recalling 54 units of Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month duration.
Boston Scientific is recalling 35 units of Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.
Boston Scientific is recalling 97 Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month duration.
Boston Scientific is recalling Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month period.
Boston Scientific is recalling 179 Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.
Boston Scientific is recalling Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.
Boston Scientific is recalling 940 Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.
Boston Scientific is recalling 109 units of Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.
Boston Scientific is recalling 66 units of Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.
Boston Scientific is recalling 139 units of Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.
Boston Scientific is recalling 66 units of Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.
Boston Scientific is recalling 271 Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.
Boston Scientific is recalling Advanix Pancreatic Stents labeled with a 36-month shelf life instead of the approved 18-month duration.