Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

CMS-2374-R4 Custom US Breast Core Biopsy Tray Recalled by Custom Medical Specialties, Inc. Due to Lack of Assurance of Sterility; the firm's medical...

Date: July 23, 2012
Company: Custom Medical Specialties, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Custom Medical Specialties, Inc. directly.

Affected Products

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.

Quantity: 25 Trays

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 3 states: GA, MD, MA

Affected (3 states)Not affected

About Custom Medical Specialties, Inc.

Custom Medical Specialties, Inc. has 21 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report