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

Recall Z-1136-2019 — PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intended for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDS II suture is not indicated in adult cardiovascular tissue, microsurgery

U.S. FDA — Device Enforcement · United States · 2019-03-12 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1136-2019
Date of alert: 2019-03-12
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Ethicon, Inc.
Product category: device
Product type: Devices

Reported risk: VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label.

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.

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.

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