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

Recall Z-1196-2014 — Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator is a sterile, two-band, dual-incision instrument. The two-band applicator enables the physician to o

U.S. FDA — Device Enforcement · United States · 2014-02-19 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1196-2014
Date of alert: 2014-02-19
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Gyrus Medical, Inc
Product category: device
Product type: Devices

Reported risk: Due to an anomaly in the packaging process for specific lots of Disposable Falope-Ring Band Kit, it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility of the product. The breach may or may not be easily seen.

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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