FDA recall Z-2208-2020

Bard Peripheral Vascular Inc · Class II · device

Product

EQUISTREAM¿ XK Long-Term Hemodialysis Catheter. REF/UDI:5913230/:(01)00801741013843; 16F

Reason for recall

Incorrect Peel-Apart Introducer Sheath in Kit.

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.

Key facts

Status
Terminated
Initiation date
2019-06-14
Report date
2020-06-10
Termination date
2024-09-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tempe, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2208-2020