Drug recall
CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS…
FDA recall event 76276 · Class II · Custom Medical Specialties, Inc.
Key facts
| Event ID | 76276 |
|---|---|
| Recall numbers | Z-1234-2017 |
| Recalling firm | Custom Medical Specialties, Inc. |
| Product type | Devices |
| Products | CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, Inc. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Sterility of syringe product could not be assured. |
| Initiation date | Sep 20, 2016 |
| Report date | Mar 1, 2017 |
| City | Pine Level |
| State | NC |
| Country | United States |
| FEI number | 3005474845 |
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: