Z-1142-2022 Class II
Recall Details
- Product Type
- Devices
- Report Date
- June 8, 2022
- Initiation Date
- April 21, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 75 units
Product Description
Locking Cap for PD Catheter Adapter
Reason for Recall
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
Distribution Pattern
US Nationwide distribution in the states of CA, MO, MA, AZ, TX, FL, NY, MD, OH.
Code Information
Product code: R5C4169; UDI: 00085412008639; Lot Number: H20K02067 (exp. date: 10/31/2025)