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Thin-Flex Venous Cannula, Model Number:TF292902A recallZ-0398-2016 · Edwards Lifesciences, LLC · initiated Nov 4, 2015

Class II Terminated All recalls posted in December 2015

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Edwards Lifesciences, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Employee error

What the company is doing

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.

Recall details

Recall number
Z-0398-2016
Recall class
Class II
Status
Terminated
Initiated by the company
Nov 4, 2015
Posted by the FDA
Dec 9, 2015
Recalling firm
Edwards Lifesciences, LLC
Quantity
8,915 units
Product code
DWF
FDA submissions
K120072
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, Saudi Arabia, Sweden, Singapore, Thailand and South Africa.

Product description

Thin-Flex Venous Cannula, Model Number:TF292902A

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

8 devices cleared under K120072 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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