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U.S. Department of Health and Human Services

Enforcement Report - Week of March 19, 2014

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Product Detail

Product Description 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 occlude both Fallopian tubes without removing the applicator from the abdominal cavity. The Falope-Ring Band and Applicator Kits are indicated for use for female sterilization (permanent contraception).
Recall Number Z-1196-2014
Classification Class II
Code Info Lots: MK761655, MK764022, MK767655, MK526401
Product Distributed Qty 856 units
Reason For Recall 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.

Event Detail

Event Id 67578
Product Type Devices
Status Ongoing
Recalling Firm Gyrus Medical, Inc
City Osseo
State MN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-02-19
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US Distribution.
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