Thin-Flex Venous Cannula, Model Number:TF292902A

FDA device recall Z-0398-2016 · posted 2015-12-09 · Terminated

Recall details

Recalling firm

Edwards Lifesciences, LLC

Reason for recall

Edwards Lifesciences initiated a field action for the Thin-Flex Venous Cannula (Model TF292902A) because the connector size is incorrectly described in the Edwards product guide as 3/8 inch. The actual and correct connector size is 1/2 inch.

Action taken

Edwards Lifesciences sent an Urgent Medical Device Safety Notice dated November 17, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customer Instructions 1. Review this field safety notice to understand the potential hazard. 2. Meet and review with appropriate clinical staff at your hospital. 3. Complete and return the acknowledgement form attached to this letter via fax to (800) 422-9329 within 5 business days of receiving this notice. 4. Distribute this notice within your organization or to any organization where the potentially affected devices have been transferred. 5. Product return is not required. Actual product is acceptable for use and is not being recalled as part of this field action. Your assistance is appreciated and necessary to ensure that this notice is reviewed and understood. We appreciate your attention, and apologize for the inconvenience caused by this matter. If you have questions that have not been answered by this letter, please call Edwards Customer Service Monday through Friday at (800) 424-3278 from 8:00AM - 4:00PM Pacific Time.

Root cause

Employee error

Status

Terminated

Product code

DWF

Quantity affected

8,915 units

Distribution

Worldwide Distribution - USA (nationwide) Distribution and to the countries of : United Arab Emirates , Belgium, Czech Republic, Spain, France, United Kingdom, Italy, Kuwait, Netherlands, Romania, Sau

Date initiated

2015-11-04

Date posted

2015-12-09

Date terminated

2017-02-10

Location

Draper, UT

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