PowerLoc MAX Power Injectable Infusion Port Access Kit; Catalog Numbers 2131910 (UDI 008017410441...
FDA Device Recall #Z-2662-2020 — Class II — June 19, 2020
Recall Summary
| Recall Number | Z-2662-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 19, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Becton Dickinson & Company |
| Location | Franklin Lakes, NJ |
| Product Type | Devices |
| Quantity | 5,296,132 total |
Product Description
PowerLoc MAX Power Injectable Infusion Port Access Kit; Catalog Numbers 2131910 (UDI 00801741044151), 2131915 (UDI 00801741044168), 2131975 (UDI 00801741044175), 2132010 (UDI 00801741044151), 2132015 (UDI 00801741044199), 2132075 (UDI 00801741044205), 2132210 (UDI 00801741044212), 2132275 (UDI 00801741044236), 2141910 (UDI 00801741044243), 2141915 (UDI 00801741044250), 2141975 (UDI 00801741044267), 2142010 (UDI 00801741044274), 2142015 (UDI 00801741044281), 2142075 (UDI 00801741044298), 2142210 (UDI 00801741044304), 2142215 (UDI 00801741044311), 2142275 (UDI 00801741044328)
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
Lot / Code Information
Catalog Numbers 2131910 (UDI 00801741044151), 2131915 (UDI 00801741044168), 2131975 (UDI 00801741044175), 2132010 (UDI 00801741044151), 2132015 (UDI 00801741044199), 2132075 (UDI 00801741044205), 2132210 (UDI 00801741044212), 2132275 (UDI 00801741044236), 2141910 (UDI 00801741044243), 2141915 (UDI 00801741044250), 2141975 (UDI 00801741044267), 2142010 (UDI 00801741044274), 2142015 (UDI 00801741044281), 2142075 (UDI 00801741044298), 2142210 (UDI 00801741044304), 2142215 (UDI 00801741044311), 2142275 (UDI 00801741044328). Lot Numbers: REDW3798 REDY2866 REDZ1719 REEN3137 REEP0951 REEQ2684 REEQ4092 REER1229 REEQ0664 REEQ1649 REER0459 REDZ1818 REEP3049 REDW1092 REDX3754 REDY1682 REDY2971 REDY3530 REDZ1070 REEN3271 REEN4480 REEP0992 REEP3957 REEQ1647 REEQ2724 REEQ4093 REER1266 REDY3719 REEN1270 REEP0952 REEQ0684 REEQ2676 REEQ4054 REER0460 REDT2879 REDU2256 REDU3371 REDU4487 REDV1088 REDV2972 REDV3470 REDW0402 REDW1087 REDX1518 REDY1804 REDY2867 REDY3531 REDZ1069 REEN1104 REEN4481 REEP0953 REEP3958 REEQ0665 REEQ1650 REER0530 REEN2139 REEP4053 REER0461 REDY3720 REEQ4094 REDW3682 REDY0827 REDZ1071 REEP0994 REER0539 REEN4551 REEP0954 REEQ1648 REDW1197 REDY2972 REDZ3130 REEP0995 REEP2909 REDW0546 REDX1519 REDX4930 REDY1683 REDY2868 REDY3532 REDZ1064 REDZ1819 REEN1046 REEN2146 REEP0955 REEP3052 REEP3959 REER0462 REDZ1721 REEQ2678 REDV1236 REDW0407 REDW0550 REDX4852 REDY0773 REDY0828 REDY1684 REDY2973 REDZ1063 REDZ1072 REDZ1820 REEN1271 REEN3273 REEP0956 REEP0996 REEP1728 REEP3053 REEP4054 REEQ1664 REEQ2720 REER0540 REDW3683 REDY3721 REEN4552 REER1261 REEN3155 REDW0403 REDY1685 REDZ1722 REEP0997 REEQ0666
Other Recalls from Becton Dickinson & Company
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1496-2026 | Class II | 10mL Non-Sterile BD Luer-Lok Tip Syringe Only. ... | Jan 27, 2026 |
| Z-0504-2026 | Class II | BD Luer Tip Caps; Catalog Number(s) or Model N... | Oct 14, 2025 |
| Z-0736-2024 | Class II | PosiFlush Prefilled Saline Syringe with General... | Nov 16, 2023 |
| Z-0349-2024 | Class II | BD Alaris Pump infusion sets (Product Name, Cat... | Oct 11, 2023 |
| Z-0351-2024 | Class II | BD Extension Sets (Product Name, Catalog #) ... | Oct 11, 2023 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.