CMS-8934 Custom Phlebectomy Tray, Sterile, contains Sodium chloride 0.9% 50 mL, Manufactured by: ...
FDA Recall #D-1650-2012 — Class II — July 23, 2012
Product Description
CMS-8934 Custom Phlebectomy 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.
Recalling Firm
Custom Medical Specialties, Inc. — Pine Level, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
20 Trays
Distribution
GA, MD, MA
Code Information
Lot #: 25915-1111, Exp 12/2012
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.