The Recall Desk
SevereFDA (Devices)·Z-2663-2020·Announced 2020-07-29

Becton Dickinson Recalls PowerLoc MAX Infusion Sets Due to Tubing Cracks

Becton Dickinson is recalling PowerLoc MAX infusion sets because tubing may crack, risking leakage of chemicals or biohazard materials.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a medical device that can lead to serious injuries such as air embolism, blood loss, and infection.

Plain-English summary

Becton Dickinson & Company is recalling PowerLoc MAX Power Injectable Infusion Sets with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kits. The recall involves specific catalog numbers and lot numbers, with a total of 5,296,132 units distributed worldwide.

The recall is due to a potential defect where cracks or breaks may develop in the tubing near the Luer or Y site. If the tubing breaks or cracks, it can cause leakage, exposing users to chemicals such as chemotherapeutics or biohazard materials like blood.

A crack or break in the tubing could result in blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination that could lead to infection. Users should check their devices for the affected catalog and lot numbers and follow instructions from the manufacturer or healthcare provider regarding the recall.

The recalled product

Product
PowerLoc MAX Power Injectable Infusion Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit; Catalog Numbers 2132010G (UDI 00801741095504), 2132015G (UDI 00801741095511), 2141910G (UDI 00801741095542), 2142010G (UDI 00801741085680), 2142015G (UDI 00801741085680), 2
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 (5)

  • Catalog Numbers 2132010G (UDI 00801741095504)
  • 2132015G (UDI 00801741095511)
  • 2141910G (UDI 00801741095542)
  • 2142010G (UDI 00801741085680)
  • 2142015G (UDI 00801741085680)

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 →