Recall Z-2246-2017 ยท KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short. 1 Unit. Sterile. Baxter Healthcare Corporation, Deerfield, IL 60015 USA
| Date | Jun 2, 2017 (initiated Apr 28, 2014) |
| Status | Terminated |
| Reason | Connection issues between the PD transfer set catheter connector and an adapter may lead to leaks and contamination of the fluid pathway which may result in peritonitis. |
| Root cause | Unknown/Undetermined by firm |
| Action | On April 28, 2014, firm sent an Urgent Product Recall to US customers via USPS 1st class mail. Baxter requested customers to locate and remove all affected product from their facility, and contact Baxter Healthcare Center for Service to arrange for return and credit. 100%, all non-respondents would be contacted by phone. All affected product would be destroyed. For general questions regarding this communication , contact The Center for One Baxter at 1-800-422-9837 , Monday through Friday, between the hours of 8:00AM and 5:00 PM Central Time. |
| Quantity | 6,048 |
| Distribution | Nationwide Distribution and Internationally to Canada and Malaysia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K882498 | EXTENDED LIFE CAPD TRANSFER SET 5C4444 Baxter Healthcare Corp, Jul 13, 1988 |