Drug recall
GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS…
FDA recall event 65255 · Class II · Gyrus Acmi, Incorporated
Key facts
| Event ID | 65255 |
|---|---|
| Recall numbers | Z-1439-2013 |
| Recalling firm | Gyrus Acmi, Incorporated |
| Product type | Devices |
| Products | GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104 Disposable myringotomy knife… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | lack of sterility assurance |
| Initiation date | May 24, 2013 |
| Report date | Jun 12, 2013 |
| Termination date | May 30, 2014 |
| City | Southborough |
| State | MA |
| Country | United States |
| FEI number | 3003790304 |
At a glance
- 1–9 Products in this recall
- 1–9 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: