Z-2246-2017 Class II Terminated
FDA device recall Z-2246-2017 was initiated by Baxter Healthcare Corporation on Apr 28, 2014 and is designated Class II. 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. The recall status is terminated (terminated Jul 21, 2017). Affected quantity: 6,048.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 14, 2017
- Initiation Date
- Apr 28, 2014
- Termination Date
- Jul 21, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,048
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.
Distribution Pattern
Nationwide Distribution and Internationally to Canada and Malaysia
Code Information
Product Code 5C4483; Lot# H12030047
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2246-2017
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026