Drug product
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.
D-1649-2012
Product summary
- Event
- Event 62775
- Status
- Terminated
- Classification
- Class II
- Quantity
- 35 Trays
- Official record key
drug-enforcement:D-1649-2012
Official wording
Reason: 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
Code information: Lot #: 25744-1111, Exp 09/2012
Distribution pattern: GA, MD, MA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility