Drug recall
CMS-2374-R4 Custom US Breast Core Biopsy Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Manufactured by…
FDA recall event 62775 · Class II · Custom Medical Specialties, Inc.
Key facts
| Event ID | 62775 |
|---|---|
| Recall numbers | D-1649-2012, D-1650-2012, D-1651-2012 |
| Recalling firm | Custom Medical Specialties, Inc. |
| Product type | Drugs |
| Products | CMS-2374-R4 Custom US Breast Core Biopsy Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Manufactured by: CMS Custom Medical Specialties, Inc., 330 East Main St, PO Box 177, Pine Level, NC 27568…, CMS-8934 Custom Phlebectomy Tray, Sterile, contains Sodium chloride 0.9% 50 mL, Manufactured by: CMS, Custom Medical Specialties, Inc., 330 East Main St, PO Box 177, Pine level, NC 27568, the tray…, Custom Access Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Re-order #: CMS-1667-R2(94-2478), Manufactured for KM Medical, Inc., 124 Jewett Street, Georgetown, MA 01833, the tray also contains… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags, Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags. |
| Initiation date | Jul 23, 2012 |
| Report date | Aug 29, 2012 |
| Termination date | Oct 11, 2012 |
| 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: