FDA-Drug2012-08-29Class II

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.

Custom Medical Specialties, Inc.
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

Sold states
GA, MD, MA
Affected count
35 Trays
Manufactured in
330 East Main Street, N/A, Pine Level, NC, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1649-2012

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