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)
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
UPCs
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDABD¿Spinal Tray with BD¿Quincke Needle 26 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405632.2026-04-27
- FDABD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 405637, 405707.2026-04-27
- FDABD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405671.2026-04-27
- FDABD¿Spinal Tray with BD¿Quincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405609.2026-04-27
- FDABD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 2 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405658.2026-04-27
- FDABD¿Spinal Tray with BD¿Quincke Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 405621, 405735.2026-04-27
- FDABD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 400866, 405672, 405673, 405674, 405675, 405709, 405721, 405723, 406704.2026-04-27
- FDABD¿Spinal Tray with BD¿Whitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405645.2026-04-27
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