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Gyrus ACMI

Gyrus ACMI, LLC · Model 002399-501 · UDI-DI 00821925000186

KNH Prescription

510(k) clearances

892

Adverse events (1 deaths)

Recalls

Facilities

Description

SCOPE, CABOT LAPAROCATOR

Recalls

Date	Firm	Reason
2014-10-21	Gyrus Acmi, Incorporated	All packages of Falope Ring Band Applicator kits are being recalled due to compromises in sterile packaging that could be associated with bacterial contamination that might lead to
2014-07-09	Richard Wolf Medical Instruments Corp.	Richard Wolf Medical Instrument Corporation is recalling Hulka Clip Tubal Occluding Device lot 51000232. The devices are being recalled as a part of an investigation into a biocomp
2014-07-08	Gyrus Medical, Inc	Falope-Ring Dilator for Reusable Falope-Ring Band Applicators have been sold as a stand-alone non-sterile component. The dilator is intended to assist placement of the Falope-Ring
2014-02-19	Gyrus Medical, Inc	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 th

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.