Becton Dickinson Recalls PowerLoc MAX Infusion Sets Due to Tubing Cracks
Becton Dickinson is recalling PowerLoc MAX infusion sets because tubing may crack, risking chemical exposure, blood loss, or infection.
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 risk of serious harm (air embolism, infection, chemical exposure) but the source text does not report any 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 approximately 5,296,132 units of PowerLoc MAX Power-Injectable Infusion Set myPICK Port Access Kits. The recall covers specific catalog numbers and lot numbers distributed worldwide.
The recall is being issued because the tubing near the Luer or Y site of the device may develop cracks or breaks. These defects can cause leakage, leading to exposure to chemicals such as chemotherapeutics or biohazard materials like blood. Additionally, cracks or breaks could result in blood loss, catheter occlusion, air embolism, interrupted infusion, or site contamination that could lead to infection.
Healthcare facilities and consumers should stop using the affected devices and contact Becton Dickinson for further instructions on replacement or disposal.
The recalled product
- Product
- PowerLoc MAX Power-Injectable Infusion Set myPICK Port Access Kit; Catalog Numbers CPA00001 (UDI 00801741098345), CPA00002 (UDI 00801741098352), CPA00028 (UDI 00801741129728), CPA00032 (UDI 00801741137501), CPA00033 (UDI 00801741137501), CPA00036 (UDI 00801741138911), CPA00051 (U
- Manufacturer
- Becton Dickinson & Company
- Category
- Medical Device — Infusion Sets
- 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 (8)
- Catalog Numbers CPA00001 (UDI 00801741098345)
- CPA00002 (UDI 00801741098352)
- CPA00028 (UDI 00801741129728)
- CPA00032 (UDI 00801741137501)
- CPA00033 (UDI 00801741137501)
- CPA00036 (UDI 00801741138911)
- CPA00051 (UDI 00801741175718)
- CPA00055 UDI 00801741182181)
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.
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