QuickDraw Venous Cannula with Insertion Kit. ThruPort Systmes. Models QD22 (22 Fr) and QD25 (25 Fr). The product is pack

FDA device recall Z-1542-2013 · posted 2013-06-13 · Terminated

Recall details

Recalling firm

Edwards Lifesciences, LLC

Reason for recall

Edwards is recalling the QuickDraw Venous Cannula due to complaints of cannula separation during withdrawal of the device when the Percutaneous insertion method is used.

Action taken

The firm, Edwards Lifesciences, sent an "URGENT FIELD SAFETY NOTICE PRODUCT RECALL - ACTION REQUIRED" notice dated May 14, 2013 to its customers. The letter described the product, problem, and actions to be taken. The customers were instructed to review our entire inventory for any QuickDraw Venus Cannula that has not expired; quarantine affected product from your inventory; discontinue use and return unused devices; complete and return the acknowledgment form via fax to Edwards Customer Service on 800-422-9329 within three days of receipt of this Field Safey Notice; contact Customer Service at 800-424-3278 to obtain a Returned Goods Authorization number and replacement product; return product to Edwards Lifesciences, Attn: Santosh Bhagat, 12050 Lone Peak Drive, Draper, UT 84020 Attention: RECALL, RGA#xxxxxx. If you have any questions that have not been answered by this notice, please call Edwards Customer Service at 800-424-3278 from the hours of 6:00AM - 4:30PM PST.

Root cause

Process design

Status

Terminated

Product code

DWS

Quantity affected

22,616

Distribution

Worldwide distribution: US Nationwide and country of Canada.

Date initiated

2013-05-14

Date posted

2013-06-13

Date terminated

2014-10-14

Location

Draper, UT

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