DuraspanTM Dialysis Catheters, Ultra and Long Term, 15.5 Fr, Sterile EO, Manufactured for r4 Vascular, Inc . 7550 Merida

FDA device recall Z-2412-2011 · posted 2011-06-06 · Terminated

Recall details

Recalling firm

R4 Vascular Inc

Reason for recall

r4 Vascular, Inc. is conducting a voluntary recall of specific lots of Duraspan Dialysis Catheters. Duraspan catheters are 15.5 Fr dual lumen chronic hemodialysis catheters. Over a six month period, seven patients at five hospitals experienced separation of the luer connector from the extension tube on the Duraspan catheter. Testing during failure analysis disclosed that these lots and other lot

Action taken

R4 Vascular Inc sent an Urgent Medical Device Recall letter dated May 3, 2011, to all affected customers. The letter described the problem and the product being recalled. Consignees were instructed to stop distributing the product and to quarantine the recalled lots and if they had already distributed the affected product to seek its return from their customers. A template letter to physicians and healthcare facilities was enclosed for Distributors/Retailers to send or hand deliver to their customers. For questions regarding this recall call 1-704-905-2105.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MSD

Quantity affected

2489 kits

Distribution

Nationwide Distribution including CA, CO, CT, FL, GA, IL, LA, MD, MA, MN, MS, MO, NJ, NC, OH, PA, SC, TX, and WA.

Date initiated

2011-05-03

Date posted

2011-06-06

Date terminated

2012-07-27

Location

Maple Grove, MN

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