FDAFDA · Food and drugs·Recall number Z-2667-2020
SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing; Catalog Number CPA00040 (UDI 00801741143892)
Published July 29, 2020 · Recall initiated: June 19, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Becton Dickinson & Company
- Distributor
- Worldwide Distribution
- Lot
- Catalog Number CPA00040 (UDI 00801741143892). Lot Numbers: REEN0219 REEP1376 REEP3657
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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