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Hulka Clips
RICHARD WOLF MEDICAL INSTRUMENTS CORP. · Model 4986.90 · UDI-DI 00861523000102
KNH
Prescription
0
510(k) clearances
892
Adverse events (1 deaths)
4
Recalls
6
Facilities
Description
Tubal Occluding Device in a sterile pouch (2 Hulka Clips per pouch)
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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Get your free API keyRead the docsData 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.