—#210515

Product

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis

FDA product code: KDJ — Set, Administration, For Peritoneal Dialysis, Disposable
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K152675
Affected lot / code info: UDI/DI 00085412007731, Lot/Serial Numbers: H23J16074, H23K01082, H23K06107, H23K09093, H23K28051, H23K30081, H23L07053, H23L13051, H23L27093, H24A03061, H24A09035, H24A11064, H24A29132, H24B02038, H24B12086, H24B21079, H24B28090, H24B29072, H24B29098, H24C21093, H24C27090, H24D08064, H24D11050, H24D17040, H24D22081, H24D26058, H24D30076, H24E06065, H24E23037, H24E28051, H24F03045, H24F05065, H24F17086, H24F24033, H24F27036, H24H05061, H24H08032, H24H13040, H24H16043, H24H22025

Why it was 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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: Worldwide distribution.

Timeline

Recall initiated: 2024-10-23
Posted by FDA: 2024-11-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210515. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.