FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-2246-2017
- Recalling firm
- Baxter Healthcare Corporation
- Product
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short. 1 Unit. Sterile. Baxter Healthcare Corporation, Deerfield, IL 60015 USA
- Status
- Terminated
- Initiated
- 2014-04-28
- Posted
- 2017-06-02
- Terminated
- 2017-07-21
- 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
- Lot, serial or model codes
- Product Code 5C4483; Lot# H12030047
- 510(k) numbers
- ["K882498"]
- PMA numbers
- not on file
- Product code
- KDJ
- Firm FEI
- 1417572
- Firm city
- Deerfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28