Z-1989-2016Class II

Excelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10 mL syringe). For flushing of IV...

Name: Z-1989-2016 Excelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10 mL syringe). For flushing of IV...
Creator: Excelsior Medical Corp
Published: 2016-04-28
License: https://open.fda.gov/license/

Excelsior Medical LLC / initiated 2016-04-28 / Terminated / root cause: manufacturing process

FDA source

Excelsior Medical Corp began a recall of Excelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10 mL syringe). For flushing of IV catheters and IV tubing only on 2016-04-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1989-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-28
Posted: 2016-06-14
Terminated: 2017-08-08
Recalling firm: Excelsior Medical LLC
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.
Product code: NZW Heparin, Vascular Access Flush
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Excelsior Medical Inc. sent a recall letter on 4/29/2016 via certified mail. Customers are instructed to discontinue using the product subject to this recall. Customers are requested to complete the customer reply form and fax it (866) 807-3714, so arrangements can be made to return the product to Excelsior.
Quantity in commerce: 184,500
Distribution: US Nationwide distribution.
Product codes and lots: Product Code, Lot number, Expiration date. 513604 3123326 7/1/2016 E0500-55 3123349 7/1/2016 513602 3126577 8/1/2017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1989-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1989-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-14

Product code NZW

K023740Class IISyrex Pre-Filled SyringeExcelsior Medical Corp. / cleared 2003-05-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)