PlainRecalls
FDA Devices Moderate Class II Ongoing

3,65 m Extension Set with Luer-lock Connector

Reported: June 8, 2022 Initiated: April 21, 2022 #Z-1145-2022

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.

Details

Units Affected
60 units
Distribution
US Nationwide distribution in the states of CA, MO, MA, AZ, TX, FL, NY, MD, OH.
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
3,65 m Extension Set with Luer-lock Connector. Recalled by Baxter Healthcare Corporation. Units affected: 60 units.
Why was this product recalled?
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 8, 2022. Severity: Moderate. Recall number: Z-1145-2022.