Z-1032-2015 Class II Terminated
FDA device recall Z-1032-2015 was initiated by Fresenius Kabi USA, LLC on Dec 19, 2014 and is designated Class II. Reason for recall: The lot failed pH specification. The recall status is terminated (terminated Jan 26, 2016). Affected quantity: Domestic: 69,725.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 4, 2015
- Initiation Date
- Dec 19, 2014
- Termination Date
- Jan 26, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Domestic: 69,725
Product Description
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
Reason for Recall
The lot failed pH specification.
Distribution Pattern
Nationwide Distribution
Code Information
Lot 6005501, Exp. Date 1/2016
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1032-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026