CLASS II ONGOING Device recall · Reported 4 Dec 2024 · FDA Enforcement Report

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp recalled

Baxter Healthcare is recalling Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp. The recall was initiated on 23 Oct 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI 00085412007748, Lot/Serial Numbers: H23J10051, H23J23062, H23K20066, H24C08033, H24E16080, H24F12046, H24F17045, H24G02045, H24I02090

Quantity recalled62,718

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0562-2025
FDA event ID: 95524
Recalling firm: Baxter Healthcare, Deerfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 23 Oct 2024
FDA classified: 27 Nov 2024
Reported: 4 Dec 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

23 Oct 2024	Recall initiated by company
27 Nov 2024	Classified by FDA	+35 days
4 Dec 2024	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis

Where it was distributed

Worldwide distribution.

Questions about this recall

Is Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp recalled?

Yes. Baxter Healthcare recalled Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp on 23 Oct 2024. The recall is Class II and its status is Ongoing. Recall number Z-0562-2025.

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.

Which lots are affected?

UDI/DI 00085412007748, Lot/Serial Numbers: H23J10051, H23J23062, H23K20066, H24C08033, H24E16080, H24F12046, H24F17045, H24G02045, H24I02090

Where was it sold?

Worldwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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