Recall Z-2246-2017— Baxter Healthcare Corporation

Name: FDA recall Z-2246-2017
Creator: U.S. Food and Drug Administration
Published: 2014-04-28

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2014-04-28, terminated 2017-07-21. It names one FDA 510(k) clearance: K882498. Product: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short. 1 Unit. Sterile. Baxter Healthcare Corporation, Deerfield, IL 60015 USA. 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..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Terminated
Initiated: 2014-04-28
Terminated: 2017-07-21
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K882498 — EXTENDED LIFE CAPD TRANSFER SET 5C4444Baxter Healthcare Corp·cleared 1988-07-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.