—#153044

Product

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short. 1 Unit. Sterile. Baxter Healthcare Corporation, Deerfield, IL 60015 USA

FDA product code: KDJ — Set, Administration, For Peritoneal Dialysis, Disposable
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K882498
Affected lot / code info: Product Code 5C4483; Lot# H12030047

Why it was recalled

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 (FDA determination)

Unknown/Undetermined by firm

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: Nationwide Distribution and Internationally to Canada and Malaysia

Timeline

Recall initiated: 2014-04-28
Posted by FDA: 2017-06-02
Terminated: 2017-07-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #153044. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.