HEPFLUSH-10 — Class II medical device recall Z-1032-2015
Terminated recall by Fresenius Kabi USA, LLC, reported 2015-02-04, distributed nationwide. The lot failed pH specification.
| Recall number | Z-1032-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, Lake Zurich, IL, United States |
| Recall initiated | 2014-12-19 |
| Classified | 2015-01-29 |
| Reported by FDA | 2015-02-04 |
| Terminated | 2016-01-26 |
| Distributed | Nationwide (US) |
| Quantity | 69,725 |
| NDC | 63323-0017-10 |
| Lot numbers | 6005501 |
| Expiration dates | 2016-01 |
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
Reason for recall
The lot failed pH specification.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1032-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.