The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis Catheterization Set

FDA device recall Z-1007-2015 · posted 2015-01-22 · Terminated

Recall details

Recalling firm

Arrow International Inc

Reason for recall

The tunneling sheath packaged within the kits can crack during placement. If the tunneling sheath cracks, it can cause a delay in treatment for the time it takes to retrieve a replacement kit.

Action taken

An Urgent Medical Device Recall Notification letter, dated February 4, 2014, was sent to direct consignees that identified the product, problem, and action to be taken. Customers were asked to discontinue use and quarantine affected inventory. The Recall Acknowledgement form should be completed and faxed back to 1-800-343-2935. A customer service representative will contact customers with a Return Goods Authorization (RGA) Number and provide instructions for the return of the product. Customers are asked to contact their local sales representative or Customer Service at 1-800-343-2935 with questions.

Root cause

Component design/selection

Status

Terminated

Product code

MSD

Quantity affected

2,480

Distribution

Worldwide Distribution -- US and Canada.

Date initiated

2013-02-04

Date posted

2015-01-22

Date terminated

2016-10-14

Location

Reading, PA

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