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Terminated

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

FDA Recall Z-2246-2017 · Posted 2017-06-02

Recalling FirmBaxter Healthcare Corporation
Recall StatusTerminated
Product CodeKDJ
Date Initiated2014-04-28
Date Terminated2017-07-21
Product Quantity6,048

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.

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.

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

Nationwide Distribution and Internationally to Canada and Malaysia

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K882498EXTENDED LIFE CAPD TRANSFER SET 5C4444Baxter Healthcare Corp · 1988-07-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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