Class II
Terminated
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.
- Company
- Custom Medical Specialties, Inc.
- Recall Initiated
- July 23, 2012
- Posted
- August 29, 2012
- Recall Number
- D-1651-2012
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 25 Trays
- Firm Location
- Pine Level, NC, United States
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.
Distribution
GA, MD, MA
Lot / Code Info
Lot #: 26124-1112, Exp 12/2012
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