Recall Z-1269-2013 ยท FPA Set, Administration, Intravascular
Baxter Healthcare Corp.
A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set, 5.7", Vol. 0.8 mL, 2 Injection Sites, Male Luer Lock Adapter, Single use only Product Usage: This device is indicated for use in blood sampling and the administration of solutions. The InterLink Injection Site feature is intended to eliminate accidental needle sticks when used in conjunction with an InterLink Cannula as part of a
| 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) Product Code 2N3371: 228,200 units |
| 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
| K925126 | INTERLINK(TM) INJECTION SITE Baxter Healthcare Corp, Jun 18, 1993 |