PlainRecalls
FDA Devices Moderate Class II Terminated

EQUISTREAM¿ XK Long-Term Hemodialysis Catheter. REF/UDI:5913190/(01)00801741013836; 16F

Reported: June 10, 2020 Initiated: June 14, 2019 #Z-2209-2020

Product Description

EQUISTREAM¿ XK Long-Term Hemodialysis Catheter. REF/UDI:5913190/(01)00801741013836; 16F

Reason for Recall

Incorrect Peel-Apart Introducer Sheath in Kit.

Details

Units Affected
400
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.
Location
Tempe, AZ

Frequently Asked Questions

What product was recalled?
EQUISTREAM¿ XK Long-Term Hemodialysis Catheter. REF/UDI:5913190/(01)00801741013836; 16F. Recalled by Bard Peripheral Vascular Inc. Units affected: 400.
Why was this product recalled?
Incorrect Peel-Apart Introducer Sheath in Kit.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 10, 2020. Severity: Moderate. Recall number: Z-2209-2020.