D-1651-2012 Class II Terminated
FDA drug recall D-1651-2012 was initiated by Custom Medical Specialties, Inc. on July 23, 2012 and is designated Class II. 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. The recall status is terminated (terminated October 11, 2012). Affected quantity: 25 Trays.
Recall Details
- Product Type
- Drugs
- Report Date
- August 29, 2012
- Initiation Date
- July 23, 2012
- Termination Date
- October 11, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25 Trays
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.
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 Pattern
GA, MD, MA
Code Information
Lot #: 26124-1112, Exp 12/2012