Recall Z-1989-2016 ยท NZW Heparin, Vascular Access Flush
Excelsior Medical Corp
Excelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10 mL syringe). For flushing of IV catheters and IV tubing only.
| Date | Jun 14, 2016 (initiated Apr 28, 2016) |
| Status | Terminated |
| 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. |
| 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 | 184,500 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023740 | SYREX PRE-FILLED SYRINGE Excelsior Medical Corp., May 13, 2003 |