Recall Z-0768-2021— Baxter Healthcare Corporation

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2020-11-10, terminated 2023-03-24. It names one FDA 510(k) clearance: K192705. Product: MiniCap Extended Life PD Transfer Set. Reason: Potential for no-flow and leaks under the twist clamp..

Recalling firm
Baxter Healthcare Corporation
Classification
Class II
Status
Terminated
Initiated
2020-11-10
Terminated
2023-03-24
Firm location
Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

MiniCap Extended Life PD Transfer Set

Reason for recall

Potential for no-flow and leaks under the twist clamp.

Data sourced from openFDA. This site is unofficial and independent of the FDA.