Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 16, 18 and 20 French, models: FEMII016A, FEMII016AS, FEMII018A, FEMII018AS, FEMII020A, and FEMII020AS.
Reported: April 23, 2014 Initiated: April 9, 2014 #Z-1466-2014
Product Description
Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 16, 18 and 20 French, models: FEMII016A, FEMII016AS, FEMII018A, FEMII018AS, FEMII020A, and FEMII020AS.
Reason for Recall
Potential for separation of dilator tips.
Details
- Recalling Firm
- Edwards Lifesciences, LLC
- Units Affected
- 13,115
- Distribution
- Nationwide, including foreign, govt/VA/Military consignees.
- Location
- Draper, UT
Frequently Asked Questions
What product was recalled? ▼
Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 16, 18 and 20 French, models: FEMII016A, FEMII016AS, FEMII018A, FEMII018AS, FEMII020A, and FEMII020AS.. Recalled by Edwards Lifesciences, LLC. Units affected: 13,115.
Why was this product recalled? ▼
Potential for separation of dilator tips.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 23, 2014. Severity: Moderate. Recall number: Z-1466-2014.
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