Recall Z-1682-2013 ยท LJH System, Irrigation, Urological
Baxter Healthcare Corp.
Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Product Code 2C4013 - Approximate Length 85" (2.2. m) Usage: Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cytoscopy, transurethral resection and arthroscopic procedures. the sets are in
| Date | Jul 10, 2013 (initiated May 15, 2013) |
| Status | Terminated |
| Reason | A firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging. |
| Root cause | Packaging |
| Action | Baxter sent an Urgent Product Recall letter dated May 15, 2013 to all affected custorners. The letter identified the affected product, problem and actions to be taken. Customers were requested to remove all affected products and return for credit by contacting Baxter Healthcare Center for Service at 888-229-0001. Customers were instructed to complete the attached Customer Reply Form and return it to Baxter by either faxing to 224-270-5457 or scanning and e-mailing the reply form to fca@baxter.com |
| Quantity | 356,728 units |
| Distribution | US Nationwide 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 |