Recall Z-1707-2012 ยท NZW Heparin, Vascular Access Flush
Excelsior Medical Corp
Heparin Lock Flush Solution 100 Unit/mL, USP 3 ml, 4 ml, 5mL, 6 ml fill in a 10 ml Flush Syringe ZR Excelsior Medical Neptune, NJ 07753 (800) 487-4276 Made in USA NDC 63807060055. Used to maintain patency of vascular access devices designed for intermittent infusion therapy. Export product for sale in Colombia are used for locking hemodialysis catheters, for heparinization of extracorporeal sys
| Date | Jun 5, 2012 (initiated May 7, 2012) |
| Status | Terminated |
| Reason | Some lots of Heparin Lock Flush, USP Syringes (3 mL fill in 10 ml syringe, 4 mL fill in 10 ml syringe, 5 mL fill in 10 ml and 6 ml in 10 ml syringe), failed Anti-Factor IIa assay for potency. |
| Root cause | Nonconforming Material/Component |
| Action | Excelsior Medical sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 4, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue using the affected product and to complete and return an attached Customer Reply Form via fax to (866) 807-3714. Contact Excelsior Medical Customer Service at (800) 487-4276 for questions regarding this recall. A second letter which included additional lots was sent out on 5/25/2012 with the date of 5/24/2012. A return response form was also included. |
| Quantity | 34,230,500 units (596 lots) |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Brazil, Canada, and Colombia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061497 | SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML Excelsior Medical Corp., Feb 23, 2007 |