Data Foundry

Medical device recalls 2020

PowerLoc MAX Power Injectable Infusion Port Access Kit — Class II medical device recall Z-2662-2020

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-2662-2020
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-DI00801741044151, 00801741044168, 00801741044175, 00801741044199, 00801741044205, 00801741044212, 00801741044236, 00801741044243, 00801741044250, 00801741044267, 00801741044274, 00801741044281, 00801741044298, 00801741044304, 00801741044311, 00801741044328
Lot numbersREDT2879, REDU2256, REDU3371, REDU4487, REDV1088, REDV1236, REDV2972, REDV3470, REDW0402, REDW0403, REDW0407, REDW0546, REDW0550, REDW1087, REDW1092, REDW1197, REDW3682, REDW3683, REDW3798, REDX1518, REDX1519, REDX3754, REDX4852, REDX4930, REDY0773, REDY0827, REDY0828, REDY1682, REDY1683, REDY1684, REDY1685, REDY1804, REDY2866, REDY2867, REDY2868, REDY2971, REDY2972, REDY2973, REDY3530, REDY3531 and 80 more
Model numbers2131910

Product

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.

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-2662-2020. 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.