Class 2 Device Recall Hemodialysis Implanted Catheter

• Date Initiated by Firm: June 14, 2019
• Create Date: June 03, 2020
• Recall Status: Open, Classified
• Recall Number: Z-2208-2020
• 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:5913230/:(01)00801741013843; 16F
• Code Information: LOT RECV3572
• Recalling Firm/ Manufacturer: Bard Peripheral Vascular Inc; 1625 W 3rd St Bldg 1; Tempe AZ 85281-2438
• For Additional Information Contact: Mr. Garth Conrad; 480-303-2602
• Manufacturer Reason for Recall: Incorrect Peel-Apart Introducer Sheath in Kit.
• FDA Determined Cause: 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: 215
• 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.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MSD and Original Applicant = OSMETECH MOLECULAR DIAGNOSTICS