Heparin I — Class III medical device recall Z-1149-2014
Terminated recall by Medefil Incorporated, reported 2014-03-12, distributed nationwide. The bar code that is printed on the Master Carton label does not correspond to the product code fully displaye
| Recall number | Z-1149-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medefil Incorporated, Glendale Heights, IL, United States |
| Recall initiated | 2014-02-19 |
| Classified | 2014-03-06 |
| Reported by FDA | 2014-03-12 |
| Terminated | 2017-09-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 1,608 master |
| Reason classes | labeling |
| NDC | 64253-0333-33 |
| Lot numbers | 10/15, 11/15, 12/15, 3/15, 5/15, 6/15, 7/15, 8/15, H113185N, H113232N, H113266N, H113291N, H113327N, H113369N, H113403N, H114120N |
Product
Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/mL, 3 mL fill in a 12 mL syringe.
Reason for recall
The bar code that is printed on the Master Carton label does not correspond to the product code fully displayed on the Master Carton label. The non-matching information can only be detected by using a bar code reader. The defective bar codes will be read as Product No. MIH-3335 ( Heparin I.V. Flush Syringe 100 units/mL; 5 mL fill in 12 mL Syringe) whereas this product is actually Product No. MIH-3333 (Heparin I.V. Flush Syringe 100 units/mL; 3 mL fill in 12 mL Syringe).
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-1149-2014. 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.