Recall Z-0831-2022— Baxter Healthcare Corporation
Class II · Ongoing
Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2022-02-25. FDA's recall record names no specific 510(k) clearance for this event. Product: MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C4483, R5C4484. Reason: Devices distributed lacked regulatory clearance..
- Recalling firm
- Baxter Healthcare Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-02-25
- Firm location
- Deerfield, IL, United States
Product description
MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C4483, R5C4484
Reason for recall
Devices distributed lacked regulatory clearance.
Data sourced from openFDA. This site is unofficial and independent of the FDA.