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.
This recall has been terminated (originally issued August 29, 2012).
- 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
- Official Source
- View on FDA website ↗
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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