Z-0560-2025 Class II Ongoing
FDA device recall Z-0560-2025 was initiated by Baxter Healthcare Corporation on October 23, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 22392 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 4, 2024
- Initiation Date
- October 23, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22392 units
Product Description
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis
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.
Distribution Pattern
Worldwide distribution.
Code Information
UDI/DI 00085412489643, Lot/Serial Numbers: H24C19063, H24G22092, H24G25061