Becton Dickinson & Company: SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing; Catalog Number CPA00040 (UDI 00801741143892)

Is my product affected?

SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing; Catalog Number CPA00040 (UDI 00801741143892)

• UPC 00801741143892

Check against the official notice below — it lists the full affected range.

What happened

Becton Dickinson & Company is recalling SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing (Catalog Number CPA00040, UDI 00801741143892) due to a potential defect that can cause cracks or breaks in the tubing near the Luer or Y site. The recall affects approximately 5.3 million units distributed worldwide, including Lot Numbers REEN0219, REEP1376, and REEP3657.

If tubing cracks or breaks develop, the device can leak, potentially exposing patients to chemotherapy drugs or blood. These breaks could result in blood loss, catheter occlusion, air embolism, interrupted infusion, or site contamination leading to infection. The source does not specify what actions affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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 a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.

Details from the source

Reason for recall: 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 a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection. Distribution: Worldwide Distribution Quantity: 5,296,132 total Lot/code info: Catalog Number CPA00040 (UDI 00801741143892). Lot Numbers: REEN0219 REEP1376 REEP3657

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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