FDA recall Z-0565-2025

Baxter Healthcare Corporation · Class II · device

Product

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis

Reason for recall

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.

Distribution

Worldwide distribution.

Key facts

Status
Ongoing
Initiation date
2024-10-23
Report date
2024-12-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0565-2025