HEPARIN LOCK FLUSH SOLUTION — Class II medical device recall Z-1825-2012
Terminated recall by App Pharmaceuticals Llc, reported 2012-06-27, distributed nationwide. CGMP Deviations: Incomplete documentation associated with test results.
| Recall number | Z-1825-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | App Pharmaceuticals Llc, Schaumburg, IL, United States |
| Recall initiated | 2010-05-20 |
| Classified | 2012-06-19 |
| Reported by FDA | 2012-06-27 |
| Terminated | 2012-06-20 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp |
| NDC | 63323-0545-01, 63323-0545-05 |
| Lot numbers | 406912, 406914, 408072 |
Product
HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-545-01, Product Code 504501; and HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 5 mL Multiple Dose Vial, 500 USP Units/5 mL, plastic vial, vial size 6 mL, NDC 63323-545-05, Product Code 504505; Rx only To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling.
Reason for recall
CGMP Deviations: Incomplete documentation associated with test results.
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-1825-2012. 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.