FDA Enforcement
Class II
Ongoing
BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F
Recall: Z-1061-2026
·
Reported January 21, 2026
Enforcement
- Recall Number
- Z-1061-2026
- Event ID
- 98147
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- HANGZHOU BEVER MEDICAL DEVICES CO., LTD.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 21, 2026
- Initiation Date
- November 29, 2025
- Classification Date
- January 12, 2026
- Address
- Building 2, No. 1-1, Houmuqiao, Yongle Village, Cangqian Street, Yuhang, Hangzhou, N/A, China
Description
BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F
Reason
Labeling error, Incorrect expiration date
Code Info
UDI: (01)06948796204063/Lot # T21823
Distribution
US Nationwide distribution in the state of GA.
Quantity
149310 units