Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8, 10, 12 French,Sterile EO, Rx Only, Manufacturer Edwards Lif

FDA device recall Z-1371-2015 · posted 2015-04-02 · Terminated

Recall details

Recalling firm

Edwards Lifesciences, LLC

Reason for recall

Edwards Lifesciences is recalling Fem-Flex II Pediatric Femoral Arterial Cannula sizes 8, 10, 12 French because of the potential of tissue damage caused by a protruding wire located at the tip of the cannula.

Action taken

The firm, Edwards, sent an "URGENT - PRODUCT RECALL - ACTION REQUIRED" letter dated March 23, 2015 via FED EX on March 27, 2015 to their customers. The letter described the product, problem, and actions to be taken. The customers were instructed to review entire inventory for the lots listed; complete and return attached acknowledgment form via fax to Edwards Customer Service at 800.422.9329. within three days of receipt of this Field Safety Notice; contact Customer Service at 800.422.3278 to obtain an RGA number and replacement product; return affected product to Edwards Lifesciences, Attn: Cirilo Chaparro, 12050 Lone Peak Drive, Draper, UT 84020, Attention: RECALL, RGA#XXX; and transfer this notice to other organizations if the affected devices have been transferred to any another facilities. If you have any questions that have not been answered by this letter, please call Edwards Customer Services at 800.424.3278 from the hours of 6:00AM - 4:30PM PST; Edwards Customer Service at (800) 268-3993 from 8:00AM 4:30PM Eastern Time or contact your Edwards sales representative concerning the recall.

Root cause

Process change control

Status

Terminated

Product code

DWF

Quantity affected

5125 units

Distribution

Nationwide Distribution.

Date initiated

2015-03-23

Date posted

2015-04-02

Date terminated

2017-04-17

Location

Draper, UT

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