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

PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067 — recall Z-2459-2018

U.S. FDA — Device Enforcement · United States · 2018-05-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2459-2018
Date of alert
2018-05-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Ethicon, Inc.
Product category
device
Product type
Devices
Reported risk: The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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.