Excelsior Medical Corp: Medical Device Recall in 2016 - (Recall #: Z-1989-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: April 28, 2016

Date Posted: June 22, 2016

Recall Number: Z-1989-2016

Event ID: 74045

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.

Status: Terminated

Product Quantity: 184,500

Code Information:

Product Code, Lot number, Expiration date. 513604 3123326 7/1/2016 E0500-55 3123349 7/1/2016 513602 3126577 8/1/2017

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated