Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1340-2018 — PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CTB-1 Needle

U.S. FDA — Device Enforcement · United States · 2018-01-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1340-2018
Date of alert
2018-01-10
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Ethicon, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10705031048829
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.