Z-2663-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 29, 2020
- Initiation Date
- June 19, 2020
- Termination Date
- July 29, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,296,132 total
Product Description
PowerLoc MAX Power Injectable Infusion Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit; Catalog Numbers 2132010G (UDI 00801741095504), 2132015G (UDI 00801741095511), 2141910G (UDI 00801741095542), 2142010G (UDI 00801741085680), 2142015G (UDI 00801741085680), 2142210G (UDI 00801741085680)
Reason for Recall
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
Distribution Pattern
Worldwide Distribution
Code Information
Catalog Numbers 2132010G (UDI 00801741095504), 2132015G (UDI 00801741095511), 2141910G (UDI 00801741095542), 2142010G (UDI 00801741085680), 2142015G (UDI 00801741085680), 2142210G (UDI 00801741085680). Lot Numbers: REDY0771 REDY2980 REEN1111 REEN4550 REER0529 REEN2070 REEP0993 REDX0120 REDW1093 REDW2530 REDX1388 REDY0772 REEN1112 REEN2779 REEP2910 REEQ4095 REER2358 REDX0188