Recall Z-0099-2014 ยท FPA Set, Administration, Intravascular
Baxter Healthcare Corp.
Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 mL, Luer Activated Valve, male Luer Lock Adapter, Sterile, nonpyrogenic, Baxter Healthcare Corporation, Deerfield IL 60015. For use with a vascular access device for the administration of drugs and solutions. The Clearlink Luer Activated Valve is an in-line injection site, which can be connected to standard male Luer ada
| Date | Oct 29, 2013 (initiated Sep 4, 2013) |
| Status | Terminated |
| Reason | The firm is issuing a voluntary recall due to the potential for pinholes in the packaging. Pinholes are a breach in the sterile barrier and could lead to potential contamination. |
| Root cause | Under Investigation by firm |
| Action | Baxter sent an Urgent Product Recall letter dated September 9, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken by Customer/User: 1. Locate and remove all affected product from your facility. If you distribute these products to other facilities or departments within your institution, please forward a copy of this communication to ensure that they locate and remove affected product from potential use. The product code and lot number can be found on the shipping carton label and individual p |
| Quantity | 3,200 units |
| Distribution | US Distribution including the states of OK, GA, CA, MN, TX and HI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112893 | CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS Baxter Healthcare Corporation, Oct 18, 2011 |