Recall
Sterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b. LAP CHOLE CDS c. MAJOR CDS d. UROLOGY MINOR CDS e. UROLOGY MAJOR CDS f. SINGLE BASIC CDS g. ORGAN RECOVERY CDS h. GENERAL ABD CDS i. BURN CDS j. MINOR k. MAJOR…
MEDLINE INDUSTRIES, LP - Northfield · 17 Nov 2022
- Status
- Recall open, classified
- Why, in the FDA's words
- “Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.”
- Recall began
- 17 Nov 2022
- Company
- MEDLINE INDUSTRIES, LP - Northfield
- Device type
- Product code (LRO)
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.