Recall Z-1145-2022— Baxter Healthcare Corporation
Class II · Ongoing
Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2022-04-21. FDA's recall record names no specific 510(k) clearance for this event. Product: 3,65 m Extension Set with Luer-lock Connector. Reason: Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error..
- Recalling firm
- Baxter Healthcare Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-04-21
- Firm location
- Deerfield, IL, United States
Product description
3,65 m Extension Set with Luer-lock Connector
Reason for recall
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
Data sourced from openFDA. This site is unofficial and independent of the FDA.