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

Recall Z-3278-2018 — Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) Product Usage: The Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) are a sterile single-use medical device providing retraction to achieve and maintain optimal visualization throughout a variety of procedures.

U.S. FDA — Device Enforcement · United States · 2018-09-04 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-3278-2018
Date of alert: 2018-09-04
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: CooperSurgical, Inc.
Product category: device
Product type: Devices

Reported risk: There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection.

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.

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