FDA Medical devices recall ·
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp… recall
- Recall number
- Z-0564-2025
- 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
- 13,608 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?
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 05413760375861, Lot/Serial Numbers: H23J18054, H24G10063
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-0564-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.