FDA Device recall Z-0398-2016
Thin-Flex Venous Cannula, Model Number:TF292902A
- FDA Device
- Class II
- terminated
- Published 2015-12-16
On 2015-12-16 the FDA classified a Class II recall of Thin-Flex Venous Cannula, Model Number:TF292902A by Edwards Lifesciences, citing 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 a….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0398-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-04 |
| Published | 2015-12-16 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Edwards Lifesciences |
| Distribution | US |
Product
Thin-Flex Venous Cannula, Model Number:TF292902A
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.
Identifiers
| code_info | Lot No: 59384061 59677936 59985533 59430941 59723695 59999044 59456603 59746454 60010418 59498228 59779239…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0398-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.