Recall Z-1270-2013 ยท FPA Set, Administration, Intravascular
Baxter Healthcare Corp.
A) Product Code 2N8220: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.7", Vol. 1.10 mL, Luer Activated Valve for IV Access, Male Luer Lock Adapter, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips; B) Product Code 2N8221: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.1", Vol. 0.85 mL, Injection Site Male Luer Lock Adapter with Retrac
| Date | May 7, 2013 (initiated Mar 28, 2013) |
| Status | Terminated |
| Reason | Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties. |
| Root cause | Packaging process control |
| Action | Baxter sent an "Urgent Product Notification" dated March 28, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taked. Customers are advised to locate and remove all of the affected products from their inventory. If the products were further distributed, consigneees are requested to notify their customers of the recall. Products can be returned for credit by contacting Baxter. An acknowledgement form is required to be compelted by customers. |
| Quantity | A) Code 2N8220: 5,950; B) Code 2N8221: 6,150; C) Code 2N8222: 1,850; D) Code 2N8223: 7,900; E) Code 6N8220: 52,200; F) C |
| Distribution | Worldwide Distribution - USA Nationwide and the countries of Puerto Rico, Brazil, Canada and Columbia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103551 | INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS, Baxter Healthcare Corp, Mar 25, 2011 |