Recall
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. AAA PACK, Model Number: DYNJ44847I; b. ABDOMINAL VASCULAR PACK, Model Number: DYNJ82578; c. ABDOMINAL VASCULAR-LF, Model…
MEDLINE INDUSTRIES, LP - Northfield · 15 May 2023
- Status
- Recall open, classified
- Why, in the FDA's words
- “Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.”
- Recall began
- 15 May 2023
- Company
- MEDLINE INDUSTRIES, LP - Northfield
- 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.