PlainRecalls
FDA Devices Moderate Class II Ongoing

5 Prong Manifold Set (with Luer Connectors)

Reported: June 8, 2022 Initiated: April 21, 2022 #Z-1143-2022

Product Description

5 Prong Manifold Set (with Luer Connectors)

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
180 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?
5 Prong Manifold Set (with Luer Connectors). Recalled by Baxter Healthcare Corporation. Units affected: 180 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-1143-2022.