SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit; Catalog Numbers PA-0031G (UDI 00801741085666), PA-0031YNG (UDI 00801741085673), PA-0032G (UDI 00801741087639), PA-0033G (UDI 00801741096433)
Check against the official notice below — it lists the full affected range.
Becton Dickinson & Company is recalling SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kits due to potential cracks or breaks that may develop in the tubing near the Luer or Y site. The affected devices include catalog numbers PA-0031G, PA-0031YNG, PA-0032G, and PA-0033G, with specific lot numbers listed. Approximately 5.3 million units were distributed worldwide.
If tubing cracks or breaks develop, the devices can leak and expose users to hazardous materials including chemotherapy drugs or blood. Potential complications from such leakage include blood loss, blocked catheters, air embolism, interrupted infusion, or site contamination that could lead to infection. The recall notice does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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 Numbers PA-0031G (UDI 00801741085666), PA-0031YNG (UDI 00801741085673), PA-0032G (UDI 00801741087639), PA-0033G (UDI 00801741096433). Lot Numbers: REEN3159 REEP3067 REEQ4064 REDS3541 REDV3438 REEN2781 REEN2145 REEP3068 REDY0835 REDZ3103
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.