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.

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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