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

Recall Z-1841-2019 — ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures

U.S. FDA — Device Enforcement · United States · 2019-04-19 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1841-2019
Date of alert: 2019-04-19
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Ethicon, Inc.
Product category: device
Product type: Devices

Reported risk: Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot

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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