Recall Z-0561-2025
Baxter Healthcare Corporation · initiated October 23, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis
Codes / lots: UDI/DI 00085412476261, Lot/Serial Numbers: H23J13063, H23J26081, H24B18059, H24B19065, H24B19099, H24B20071, H24C18065, H24E22062, H24F11048
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.
FDA-determined cause: Under Investigation by firm
Action taken
Baxter issued a SAFETY ALERT notice to its consignees on 10/23/2024 via USPS first class mail. The notice explains the issue and potential hazard involved. The notice addressed to dialysis providers indicated that if a patient contacts your clinic experiencing separation of the transfer set, to replace their transfer set and contact Baxter. Notices addressed to peritoneal patients provided the following instructions: "If you experience a separation of the transfer set, please close the transfer set twist clamp and do not cut the patient line. Contact your doctor and/or nurse immediately to arrange for a transfer set replacement and further guidance." Distributors were directed to notify their customers. For general questions regarding this communication, please contact Baxter Renal Home Care Services which can be reached at 800-284-4060, option 1, between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday.
Details
- Recall number
- Z-0561-2025
- Initiated
- October 23, 2024
- Posted by FDA
- November 27, 2024
- Product code
- KDJ – Set, Administration, For Peritoneal Dialysis, Disposable
- Quantity
- 31248 units
- Distribution
- Worldwide distribution.
- Recalling firm
- Baxter Healthcare Corporation, Deerfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0559-2025 Class II | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use…There has been an increase in the number of complaints related to the separation of the female connector… | 10/23/2024Open, Classified |
| Z-0560-2025 Class II | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use…There has been an increase in the number of complaints related to the separation of the female connector… | 10/23/2024Open, Classified |
| Z-0562-2025 Class II | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use…There has been an increase in the number of complaints related to the separation of the female connector… | 10/23/2024Open, Classified |
| Z-0563-2025 Class II | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use…There has been an increase in the number of complaints related to the separation of the female connector… | 10/23/2024Open, Classified |
| Z-0564-2025 Class II | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use…There has been an increase in the number of complaints related to the separation of the female connector… | 10/23/2024Open, Classified |
| Z-0565-2025 Class II | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use…There has been an increase in the number of complaints related to the separation of the female connector… | 10/23/2024Open, Classified |
| Z-0566-2025 Class II | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use…There has been an increase in the number of complaints related to the separation of the female connector… | 10/23/2024Open, Classified |
| Z-0567-2025 Class II | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use…There has been an increase in the number of complaints related to the separation of the female connector… | 10/23/2024Open, Classified |
| Z-0568-2025 Class II | Baxter MiniCap Extended Life PD Transfer Set (long) with Titanium Spike, Part Number…There has been an increase in the number of complaints related to the separation of the female connector… | 10/23/2024Open, Classified |
| Z-0569-2025 Class II | Baxter MiniCap Extended Life PD Transfer Set (short) with Titanium Spike, Part Number…There has been an increase in the number of complaints related to the separation of the female connector… | 10/23/2024Open, Classified |