Recall
Custom convenience kits containing Medline brand Sterile Pre-Saturated Povidone Iodine Sponge Products, labeled as follows: Part Description Part Number ABDOMINAL HYSTERECTOMY DYNJ906478 ABDOMINAL HYSTERECTOMY DYNJ906478A ACCESSORY HIP…
Medline Industries Inc · 9 March 2020
- Status
- Recall terminated
- Why, in the FDA's words
- “Medline identified that there may be a potential for voids in the packaging seal and loss of sterility on the outside of the foil pouch.”
- Recall began
- 9 March 2020
- Company
- Medline Industries Inc
- 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.