FDA Medical devices recall ·

Baxter MiniCap Extended Life PD Transfer Set (long) with Titanium Spike… recall

Recall number
Z-0568-2025
Date
(initiated October 23, 2024)
Company / brand
Baxter Healthcare Corporation
1 Baxter Pkwy, Deerfield, IL, United States
Category
Medical devices › Class II
Classification
Class II
Status
Ongoing
Units affected
1536 units
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

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

Why was it recalled?

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.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

UDI/DI 0085412150710, Lot/Serial Numbers: H24E15066

Distribution

Worldwide distribution.

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-0568-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.