FDAClass IIAugust 29, 2012

CMS-2374-R4 Custom US Breast Core Biopsy Tray recall: Sterility Concern

CMS-2374-R4 Custom US Breast Core Biopsy Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Manufactured by: CMS Custom Medical Specialties, Inc.…

Why was CMS-2374-R4 Custom US Breast Core Biopsy Tray 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 26124-1112, Exp 12/2012

Product
CMS-2374-R4 Custom US Breast Core Biopsy Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Manufactured by: CMS Custom Medical Specialties, Inc.…
Recalling firm
Custom Medical Specialties, Inc.
Quantity
25 Trays
Distribution
GA, MD, MA
Recall date
August 29, 2012
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls