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

Firm: Custom Medical Specialties, Inc.

Classification: Class II

Status: Terminated

Report Date: 20120829

Initiation Date: 20120723

Termination Date: 20121011

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.

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.