FDAFDA · Food and drugs·Recall number D-1649-2012
Custom Access Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Re-order #: CMS-1667-R2(94-2478), Manufactured for KM Medical, Inc., 124 Jewett Street, Georgetown, MA 01833, the tray also contains other components not listed in this product description.
Published August 29, 2012 · Recall initiated: July 23, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · FAX
Recall details
- Manufacturer
- Custom Medical Specialties, Inc.
- Distributor
- GA, MD, MA
- Lot
- Lot #: 25744-1111, Exp 09/2012
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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