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Recall Observatory FDA recall evidence

Device product

Baxter MiniCap Extended Life PD Transfer Set (long) with Titanium Spike, Part Number T5C4325K; use in Peritoneal Dialysis

Z-0568-2025

October 23, 2024

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 95524
Status
Ongoing
Classification
Class II
Quantity
1536 units
Official record key
device-enforcement:Z-0568-2025

Official wording

Reason: 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.

Code information: UDI/DI 0085412150710, Lot/Serial Numbers: H24E15066

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.