Device product
HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only -- Fresenius Kabi USA, LLC -- NDC 63323-017-10, Product Code 1710
Z-1032-2015
Product summary
- Event
- Event 70050
- Status
- Terminated
- Classification
- Class II
- Quantity
- Domestic: 69,725
- Official record key
device-enforcement:Z-1032-2015
Official wording
Reason: The lot failed pH specification.
Code information: Lot 6005501, Exp. Date 1/2016
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
The lot failed pH specification.