FDA Enforcement
Class II
Terminated
EQUISTREAM¿ XK Long-Term Hemodialysis Catheter. REF/UDI:5913190/(01)00801741013836; 16F
Recall: Z-2209-2020
·
Reported June 10, 2020
Enforcement
- Recall Number
- Z-2209-2020
- Event ID
- 85510
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Bard Peripheral Vascular Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 10, 2020
- Initiation Date
- June 14, 2019
- Classification Date
- June 2, 2020
- Termination Date
- September 18, 2024
- Address
- 1625 W 3rd St Bldg 1, N/A, Tempe, AZ, 85281-2438, United States
Description
EQUISTREAM¿ XK Long-Term Hemodialysis Catheter. REF/UDI:5913190/(01)00801741013836; 16F
Reason
Incorrect Peel-Apart Introducer Sheath in Kit.
Code Info
RECT0999
Distribution
67 US Consignees. US - AL, AR, AZ, CA, FL, GA, IA, ID, IL, KY, LA, MD, MN, MT, NC, NY, OR, PA, TN, TX, VA, WA, WI and WV.
Quantity
400