FDA (Devices) recall action 79541
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from date of manufacture.
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.
Ethicon, Inc. is recalling PDS Plus Antibacterial Sutures because three lots were labeled with a five-year expiry date instead of the correct two-year date.
Ethicon, Inc. is recalling specific lots of PDS Plus Antibacterial Sutures because they were labeled with an incorrect expiry date of five years instead of two.
Ethicon is recalling PDS Plus Antibacterial Sutures because three lots were labeled with an incorrect five-year expiry date instead of the correct two-year date.