Recall
Halyard KIT, CARDIAC ROBOTIC - Medical convenience kits Model Number: ESJH017-03
AVID Medical, Inc. · 20 Sept 2024
- Status
- Recall open, classified
- Why, in the FDA's words
- “Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions”
- Recall began
- 20 Sept 2024
- Company
- AVID Medical, Inc.
- Device type
- Product code (OEZ)
What it means
A recall is the FDA's record that a company is correcting or removing a device because of a problem. Many are fixed with a software update or new instructions; the record does not say whether anyone was hurt. See our plain guide to FDA terms.
The record
The FDA publishes this record in its public device database. The summary documents the company filed, when available, are linked from the FDA's page.