Drug recall
Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES, INC.: (a) CMS-4153-R2 MPM…
FDA recall event 77962 · Class II · Custom Assemblies Inc
Key facts
| Event ID | 77962 |
|---|---|
| Recall numbers | Z-3059-2017 |
| Recalling firm | Custom Assemblies Inc |
| Product type | Devices |
| Products | Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES, INC.: (a) CMS-4153-R2 MPM Biopsy TRAY (b) CMS-5832-R1 Custom Safety Mammo Biopsy Tray (c) CMS-4108 Multipurpose Safety… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The firm manufactured and distributed custom surgical kits which contained BD SafetyGlide" 22GA 1¿ inch Needles. BD subsequently recalled these needles because, " Loose polypropylene particulate in… |
| Initiation date | Jun 15, 2017 |
| Report date | Aug 30, 2017 |
| Termination date | Aug 28, 2017 |
| City | Pine Level |
| State | NC |
| Country | United States |
| FEI number | 3000718854 |
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: