—#141923

Product

Thin-Flex Venous Cannula, Model Number:TF292902A

FDA product code: DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K120072
Affected lot / code info: Lot No: 59384061 59677936 59985533 59430941 59723695 59999044 59456603 59746454 60010418 59498228 59779239 60106398 59545464 59846864 60113045 59580433 59883622 60121142 59608030 59931290 60172116 59649580 59963196 60181079

Why it was recalled

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.

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Edwards Lifesciences, LLC
Address: 12050 Lone Peak Pkwy, Draper, Utah 84020-9414

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) Distribution and to the countries of : United Arab Emirates , Belgium, Czech Republic, Spain, France, United Kingdom, Italy, Kuwait, Netherlands, Romania, Saudi Arabia, Sweden, Singapore, Thailand and South Africa.

Timeline

Recall initiated: 2015-11-04
Posted by FDA: 2015-12-09
Terminated: 2017-02-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #141923. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.