Drug recall
Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm…
FDA recall event 67578 · Class II · Gyrus Medical, Inc
Key facts
| Event ID | 67578 |
|---|---|
| Recall numbers | Z-1196-2014 |
| Recalling firm | Gyrus Medical, Inc |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Feb 19, 2014 |
| Report date | Mar 19, 2014 |
| Termination date | Apr 14, 2015 |
| City | Osseo |
| State | MN |
| Country | United States |
| FEI number | 2183680 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: