Recall Z-1010-2015 ยท OCX Endoscopic Irrigation/Suction System
Baxter Healthcare Corp.
Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Containers, Approximate Length 85" (2.2 m)
| Date | Jan 26, 2015 (initiated Jan 14, 2015) |
| Status | Terminated |
| Reason | Potential for failure of the pouch packaging seal at high altitudes. |
| Root cause | Package design/selection |
| Action | 1. Locate and remove all affected product from your facility. The product code and lot number can be found on the individual product or shipping carton. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. Baxter Healthcare Center for Service can be reached at 888-229-0001 between the hours of 7:00 AM and 6:00 PM Central Time, Monday through Friday. Please have your Baxter 8-digit ship-to account number, product code, lot number(s) and quantity of product to be returned ready when calling. 3. Complete the enclosed Customer Reply Form and return it to Baxter by faxi |
| Quantity | 26,028 units |
| Distribution | US Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960787 | TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETS Baxter Healthcare Corp, May 14, 1996 |