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

Recall Z-2450-2018 — PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988

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-2450-2018
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.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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