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PowerLoc MAX Power Injectable Infusion Set; Catalog Numbers 0131910 (UDI 00801741047329), 0131915...

FDA Device Recall #Z-2670-2020 — Class II — June 19, 2020

Recall Summary

Recall Number Z-2670-2020
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 Set; Catalog Numbers 0131910 (UDI 00801741047329), 0131915 (UDI 00801741047336), 0131975 (UDI 00801741047343), 0132010 (UDI 00801741047350), 0132015 (UDI 00801741047367), 0132075 (UDI 00801741047374), 0132210 (UDI 00801741047381), 0132215 (UDI 00801741047398), 0132275 (UDI 00801741047404), 0141910 (UDI 00801741047411), 0141915 (UDI 00801741047428), 0141975 (UDI 00801741047435), 0142010 (UDI 00801741047442), 0142015 (UDI 00801741047459), 0142075 (UDI 00801741047466), 0142210 (UDI 00801741047473), 0142215 (UDI 00801741047480), 0142275 (UDI 00801741047497)

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 0131910 (UDI 00801741047329), 0131915 (UDI 00801741047336), 0131975 (UDI 00801741047343), 0132010 (UDI 00801741047350), 0132015 (UDI 00801741047367), 0132075 (UDI 00801741047374), 0132210 (UDI 00801741047381), 0132215 (UDI 00801741047398), 0132275 (UDI 00801741047404), 0141910 (UDI 00801741047411), 0141915 (UDI 00801741047428), 0141975 (UDI 00801741047435), 0142010 (UDI 00801741047442), 0142015 (UDI 00801741047459), 0142075 (UDI 00801741047466), 0142210 (UDI 00801741047473), 0142215 (UDI 00801741047480), 0142275 (UDI 00801741047497). Lot Numbers: ASCXF007 ASCXF019 ASDRF074 ASDRF075 ASDRF079 ASDRF084 ASDVF021 ASCXF001 ASDNF040 ASDNF043 ASDVF031 ASDWF118 ASCXF006 ASCXF018 ASDRF053 ASDRF058 ASDRF060 ASDRF071 ASDVF029 ASDWF117 ASCYF028 ASCYF029 ASCZF025 ASDPF029 ASDQF015 ASDQF039 ASDQF041 ASDRF065 ASDTF043 ASDTF054 ASDTF055 ASDTF061 ASDVF018 ASCYF023 ASCYF024 ASDTF031 ASDTF032 ASDTF033 ASDTF037 ASDTF038 ASCYF040 ASCYF076 ASCZF055 ASDNF001 ASDNF002 ASDNF004 ASDNF018 ASDQF036 ASDTF075 ASDTF096 ASDTF104 ASDTF105 ASDTF115 ASDUF006 ASDUF019 ASDUF026 ASDUF033 ASDUF042 ASDUF059 ASDUF063 ASDUF078 ASDUF097 ASDUF102 ASDUF105 ASDUF111 ASDUF119 ASDVF005 ASDVF014 ASDWF070 ASDWF081 ASDWF086 ASDWF102 ASDWF114 ASDTF023 ASDTF024 ASDTF025 ASDTF034 ASDTF035 ASCYF020 ASDTF027 ASDTF028 ASDTF036 ASCYF021 ASCYF022 ASDTF016 ASDTF017 ASDTF018 ASDTF019 ASDWF106 ASCXF009 ASCXF010 ASDRF088 ASDRF089 ASDRF092 ASDRF095 ASDRF096 ASDXF071 ASDXF073 ASENF043 ASENF047 ASENF048 ASCXF002 ASDNF042 ASDXF083 ASDXF084 ASCXF005 ASCXF008 ASDSF028 ASDSF032 ASDSF044 ASDSF051 ASDSF055 ASDSF056 ASENF061 ASENF075 ASEQF074 ASEQF086 ASEQF099 ASDNF027 ASDNF031 ASDNF035 ASDNF038 ASDQF021 ASDQF025 ASDQF030 ASDVF088 ASDWF003 ASDWF009 ASDWF012 ASDWF019 ASDWF072 ASERF011 ASDQF002 ASDQF003 ASDQF004 ASDQF006 ASDTF101 ASDVF084 ASDXF036 ASDXF037 ASCZF056 ASCZF062 ASDNF003 ASDNF005 ASDNF029 ASDNF032 ASDNF037 ASDNF046 ASDNF052 ASDTF040 ASDTF044 ASDTF059 ASDTF076 ASDTF098 ASDTF106 ASDUF003 ASDUF009 ASDUF021 ASDUF028 ASDUF043 ASDUF060 ASDUF077 ASDUF095 ASDUF108 ASDUF112 ASDWF073 ASDWF082 ASDWF091 ASDWF092 ASDWF113 ASDWF120 ASDXF002 ASDXF015 ASDZF021 ASDZF029 ASDZF037 ASDZF047 ASENF007 ASENF069 ASENF079 ASENF083 ASEPF007 ASCYF018 ASCYF019 ASCZF026 ASDRF047 ASDRF048 ASDRF049 ASDRF050 ASDXF049 ASDXF050 ASENF026 ASENF027 ASENF028 ASERF006 ASERF007 ASCYF007 ASDRF063 ASCYF005 ASCYF006 ASDRF009 ASDRF015 ASDRF016 ASDRF028 ASDVF068 ASDZF060 ASDZF063 ASDZF066 ASDZF068 ASERF026 ASERF028

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.

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