CLASS I ONGOING Device recall · Reported 27 Nov 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, distributed nationwide in the US. The recall was initiated on 21 Oct 2024 and the FDA has classified it as Class I.
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-0378-2025
- FDA event ID
- 95525
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 21 Oct 2024
- FDA classified
- 20 Nov 2024
- Reported
- 27 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 21 Oct 2024 | Recall initiated by company | |
| 20 Nov 2024 | Classified by FDA | +30 days |
| 27 Nov 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
Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
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 (US Nationwide distribution)
Questions about this recall
Why was it recalled?
Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
Which lots are affected?
UDI/DI 05413760375861, Lot/Serial Numbers: All lots including and manufactured after H19K04041
Where was it sold?
Worldwide Distribution (US Nationwide 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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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
9 other products · FDA event 95525This 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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