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
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-0564-2025
- 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 R5C4482E; use in Peritoneal Dialysis
Where it was distributed
Worldwide distribution.
Questions about this recall
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 05413760375861, Lot/Serial Numbers: H23J18054, H24G10063
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
10 other products · FDA event 95524This product is part of a recall event; the main page for the event is Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp recalled.
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