FDA Medical devices recall ·
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0378-2025
- Date
- (initiated October 21, 2024)
- Company / brand
- Baxter Healthcare Corporation
1 Baxter Pkwy, Deerfield, IL, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 58,680 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis
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.
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 05413760375861, Lot/Serial Numbers: All lots including and manufactured after H19K04041
Distribution
Worldwide Distribution (US Nationwide distribution)
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-0378-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.