FDA Device recall Z-1824-2012
HEPARIN LOCK FLUSH SOLUTION, USP, 10 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-544-01, Product Code 50…
- FDA Device
- Class II
- terminated
- Published 2012-06-27
On 2012-06-27 the FDA classified a Class II recall of HEPARIN LOCK FLUSH SOLUTION, USP, 10 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-544-01, Product Code 50… by App Pharmaceuticals, citing CGMP Deviations: Incomplete documentation associated with test results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1824-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2010-05-20 |
| Published | 2012-06-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | App Pharmaceuticals |
| Distribution | US |
Product
HEPARIN LOCK FLUSH SOLUTION, USP, 10 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-544-01, Product Code 504401, Rx only To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling.
Reason
CGMP Deviations: Incomplete documentation associated with test results.
Identifiers
| code_info | Lot 406952 (Expiration Date 02/11) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1824-2012%22
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