Z-1989-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 22, 2016
- Initiation Date
- April 28, 2016
- Termination Date
- August 8, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 184,500
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.
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.
Distribution Pattern
US Nationwide distribution.
Code Information
Product Code, Lot number, Expiration date. 513604 3123326 7/1/2016 E0500-55 3123349 7/1/2016 513602 3126577 8/1/2017