Enforcement Report - Week of August 29, 2012
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Product Detail
| Product Description | 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, the tray also contains other components not listed in this product description. |
|---|---|
| Recall Number | D-1651-2012 |
| Classification | Class II |
| Code Info | Lot #: 26124-1112, Exp 12/2012 |
| Product Distributed Qty | 25 Trays |
| 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. |
Event Detail
| Event Id | 62775 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Custom Medical Specialties, Inc. |
| City | Pine Level |
| State | NC | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-07-23 |
| Initial Firm Notification of Consignee or Public | FAX |
| Distribution Pattern | GA, MD, MA |
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