Excelsior Disposable Syringe Heparin Lock Flush — Class II medical device recall Z-1989-2016
Terminated recall by Excelsior Medical Corp, reported 2016-06-22, distributed nationwide. Certain lots of Heparin Lock Flush, USP Syringes (5 ml Fill in 10 ml Syringe) failed Anti-Factor IIa assay for
| Recall number | Z-1989-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Excelsior Medical Corp, Neptune, NJ, United States |
| Recall initiated | 2016-04-28 |
| Classified | 2016-06-14 |
| Reported by FDA | 2016-06-22 |
| Terminated | 2017-08-08 |
| Distributed | Nationwide (US) |
| Quantity | 184,500 |
| Reason classes | potency |
| Lot numbers | 3123326, 3123349, 3126577, 513602, 513604, E0500-55 |
Product
Excelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10 mL syringe). For flushing of IV catheters and IV tubing only.
Reason for recall
Certain lots of Heparin Lock Flush, USP Syringes (5 ml Fill in 10 ml Syringe) failed Anti-Factor IIa assay for potency during testing of retention samples for heparin potency.
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-1989-2016. 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.