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U.S. Department of Health and Human Services

Class 2 Device Recall Hemodialysis Implanted Catheter

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  Class 2 Device Recall Hemodialysis Implanted Catheter see related information
Date Initiated by Firm June 14, 2019
Create Date June 03, 2020
Recall Status1 Completed
Recall Number Z-2209-2020
Recall Event ID 85510
510(K)Number K090901  
Product Classification Catheter, hemodialysis, implanted - Product Code MSD
Product EQUISTREAM¿ XK Long-Term Hemodialysis Catheter. REF/UDI:5913190/(01)00801741013836; 16F
Code Information RECT0999
Recalling Firm/
Bard Peripheral Vascular Inc
1625 W 3rd St Bldg 1
Tempe AZ 85281-2438
For Additional Information Contact Mr. Garth Conrad
Manufacturer Reason
for Recall
Incorrect Peel-Apart Introducer Sheath in Kit.
FDA Determined
Cause 2
Error in labeling
Action On 06/14/2019, an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter was sent to each of the US consignees via FedEx with proof of delivery notification.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MSD and Original Applicant = OSMETECH MOLECULAR DIAGNOSTICS