High FDA (Devices)·Z-2662-2020·Announced 2020-07-29

Becton Dickinson Recalls PowerLoc MAX Infusion Port Access Kits

Becton Dickinson is recalling PowerLoc MAX Power Injectable Infusion Port Access Kits due to potential tubing cracks that may cause leakage of hazardous materials.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The source text describes potential for serious harm (air embolism, infection, exposure to chemotherapeutics) but does not report specific injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Becton Dickinson & Company is recalling the PowerLoc MAX Power Injectable Infusion Port Access Kit. The recall involves 5,296,132 units distributed worldwide. The affected products include specific catalog numbers and lot numbers listed in the official recall notice.

The recall is issued because the tubing near the Luer or Y site of the device may develop cracks or breaks. These defects can cause leakage, exposing users to chemicals such as chemotherapeutics or biohazard materials like blood. The source text notes that such cracks could result in blood loss, catheter occlusion, air embolism, interrupted infusion, or site contamination leading to infection.

Healthcare facilities and users should identify affected units by checking the catalog and lot numbers provided in the recall documentation. Users should stop using the affected devices and contact Becton Dickinson for instructions on replacement or return.

The recalled product

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)
Manufacturer: Becton Dickinson & Company
Category: Medical Device — Infusion Port Access Kit
Hazard: tubing-crack
chemical-exposure
infection
air-embolism
Affected units: 5,296,132

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (16)

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)

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 12 recalled by Becton Dickinson & Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 12 products in this recall →

Same manufacturer · Becton Dickinson & Company

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