Recall Z-1142-2022
Baxter Healthcare Corporation · initiated April 21, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Locking Cap for PD Catheter Adapter
Codes / lots: Product code: R5C4169; UDI: 00085412008639; Lot Number: H20K02067 (exp. date: 10/31/2025)
Reason for recall
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
FDA-determined cause: No Marketing Application
Action taken
An Urgent Medical Device Recall communication was sent to affected peritoneal dialysis centers via U.S.P.S., first class mail on 04/21/2022. Instructions within the communication request customers to locate and return any unused affected product codes and lots from their facility, contact Baxter Healthcare Center for Service to arrange for return and credit at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday, and acknowledge the receipt of this notification by completing a reply form on the customer portal or by returning a reply form in the enclosed pre-addressed stamped envelope. The home patient letter was sent on Tuesday, April 26, 2022, via USPS first-class mail.
Details
- Recall number
- Z-1142-2022
- Initiated
- April 21, 2022
- Terminated
- May 27, 2026
- Product code
- KDJ – Set, Administration, For Peritoneal Dialysis, Disposable
- Quantity
- 75 units
- Distribution
- US Nationwide distribution in the states of CA, MO, MA, AZ, TX, FL, NY, MD, OH.
- Recalling firm
- Baxter Healthcare Corporation, Deerfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1141-2022 Class II | 15 Liters Drain BagCertain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within… | 04/21/2022Terminated |
| Z-1143-2022 Class II | 5 Prong Manifold Set (with Luer Connectors)Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within… | 04/21/2022Terminated |
| Z-1144-2022 Class II | Effluent Sample BagCertain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within… | 04/21/2022Terminated |
| Z-1145-2022 Class II | 3,65 m Extension Set with Luer-lock ConnectorCertain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within… | 04/21/2022Terminated |
| Z-1146-2022 Class II | APD Drain ManifoldCertain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within… | 04/21/2022Terminated |