High FDA (Devices)·Z-2670-2020·Announced 2020-07-29

Becton Dickinson Recalls PowerLoc MAX Infusion Sets Due to Tubing Cracks

Becton Dickinson is recalling PowerLoc MAX Power Injectable Infusion Sets because tubing may crack or break near the Luer or Y site, risking leakage of chemicals or blood.

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 involves a medical device with a defect that could lead to serious harm, such as air embolism or infection, but the source text does not report any actual injuries or illnesses, 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 PowerLoc MAX Power Injectable Infusion Sets. The recall involves 5,296,132 units distributed worldwide. The affected catalog numbers include 0131910, 0131915, 0131975, 0132010, 0132015, 0132075, 0132210, 0132215, 0132275, 0141910, 0141915, 0141975, 0142010, 0142015, 0142075, 0142210, 0142215, and 0142275.

The recall is due to the 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 as chemotherapeutics or biohazard material, including 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.

The source text does not specify specific consumer actions or report any illnesses or injuries associated with this defect.

The recalled product

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
Manufacturer: Becton Dickinson & Company
Category: Medical Device — Infusion Set
Hazard: tubing-crack
leakage
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 (17)

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)

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 →

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Same hazard · tubing crack