Recall Z-1989-2016— Excelsior Medical Corp
Class II · Terminated
Class II FDA medical device recall by Excelsior Medical Corp, initiated 2016-04-28, terminated 2017-08-08. It names one FDA 510(k) clearance: K023740. 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: 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..
- Recalling firm
- Excelsior Medical Corp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-04-28
- Terminated
- 2017-08-08
- Firm location
- Neptune, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.