Ethicon recalls PDS Plus Antibacterial Suture with incorrect 5-year expiry label instead of 2-year. Affected lots may expire prematurely.
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.
Ethicon is recalling PDS Plus Antibacterial sutures that have an incorrect expiry date label. The label shows a 5-year expiry instead of the correct :2-year expiry, which could lead to using expired sutures.
The suture label shows a 5-year expiry date instead of the correct 2-year expiry. This means the suture could expire earlier than intended, potentially leading to reduced effectiveness or safety issues during medical procedures.
Medical professionals who purchased the recalled sutures are affected. Patients using these sutures during surgery may be at risk if the suture expires prematurely.
Check for the product code PDP346H and GTIN 10705031048126. The affected lot number is LL6459 with an incorrect expiry date label.
Verify the expiry date on the label matches the correct 2-year period from manufacture date.
The suture label shows a 5-year expiry date instead of the correct 2-year expiry date.
The official recall notice does not specify a remedy for this issue.
Look for product code PDP346H, GTIN 10705031048126, and lot number LL6459 with an incorrect expiry date label.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-1338-2018 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-1338-2018 from Ethicon. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.