Data Foundry

Medical device recalls 2020

PowerLoc MAX Power Injectable Infusion Set — Class II medical device recall Z-2670-2020

Terminated recall by Becton Dickinson & Company, reported 2020-07-29. Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that ha

Recall numberZ-2670-2020
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmBecton Dickinson & Company, Franklin Lakes, NJ, United States
Recall initiated2020-06-19
Classified2020-07-18
Reported by FDA2020-07-29
Terminated2022-07-29
Quantity5,296,132 total
Reason classespackaging, device malfunction
UPC / GTIN / UDI-DI00801741047329, 00801741047336, 00801741047343, 00801741047350, 00801741047367, 00801741047374, 00801741047381, 00801741047398, 00801741047404, 00801741047411, 00801741047428, 00801741047435, 00801741047442, 00801741047459, 00801741047466, 00801741047473, 00801741047480, 00801741047497
Lot numbersASCXF001, ASCXF002, ASCXF005, ASCXF006, ASCXF007, ASCXF008, ASCXF009, ASCXF010, ASCXF018, ASCXF019, ASCYF005, ASCYF006, ASCYF007, ASCYF018, ASCYF019, ASCYF020, ASCYF021, ASCYF022, ASCYF023, ASCYF024, ASCYF028, ASCYF029, ASCYF040, ASCYF076, ASCZF025, ASCZF026, ASCZF055, ASCZF056, ASCZF062, ASDNF001, ASDNF002, ASDNF003, ASDNF004, ASDNF005, ASDNF018, ASDNF027, ASDNF029, ASDNF031, ASDNF032, ASDNF035 and 171 more
Model numbers0131910

Product

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2670-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.