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Recall Observatory FDA recall evidence

Device product

Thin-Flex Venous Cannula, Model Number:TF292902A

Z-0398-2016

November 04, 2015

Class II

Product summary

Firm
Edwards Lifesciences, LLC
Event
Event 72667
Status
Terminated
Classification
Class II
Quantity
8,915 units
Official record key
device-enforcement:Z-0398-2016

Official wording

Reason: 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.

Code information: 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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.