Recall
Anti-fog solution packaged in a Tyvek peel pouch and it is placed into various kits. Kit are labeled as follows: ROBOTIC GENERAL, LAP CHOLE, GENERAL LAPAROSCOPY PACK-LF, T&A PACK, LAP CHOLE PACK-LF, LAPAROSCOPY PACK-LF, EAR ACCESSORY…
Medline Industries, Inc. · 30 May 2019
- Status
- Recall open, classified
- Why, in the FDA's words
- “The Anti-Fog Solution may not defog properly due to a degradation in the chemical properties.”
- Recall began
- 30 May 2019
- Company
- Medline Industries, Inc.
- Device type
- Product code (OCT)
- Concerns
- K982465
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.