The Recall Desk
SevereFDA (Devices)·Z-2660-2020·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 cracks may cause 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 medical device defect that can lead to serious injuries such as air embolism, infection, and exposure to hazardous chemicals.

Plain-English summary

Becton Dickinson & Company is recalling the PowerLoc MAX Power Injectable Infusion Set AllPoints Port Access System. The recall covers catalog numbers AN132075, AN142010, AN142010G, and AN142075, with a total of 5,296,132 units distributed worldwide.

The recall is due to the potential development of cracks or breaks in the tubing near the Luer or Y site. These defects can cause leakage, resulting in exposure to chemicals such as chemotherapeutics or biohazard materials like blood. A crack or break could also result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.

Healthcare providers and facilities should check their inventory for the affected catalog numbers and lot numbers listed in the official recall notice. 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 Set AllPoints Port Access System; Catalog Numbers AN132075 (UDI 00801741118968), AN142010 (UDI 00801741119231), AN142010G (UDI 00801741119323), AN142075 (UDI 00801741119224)
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 (3)

  • Catalog Numbers AN132075 (UDI 00801741118968)
  • AN142010 (UDI 00801741119231)
  • AN142010G (UDI 00801741119323)

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 →