Official recall notice
FDA DeviceClass IINotable
FDA Recall: Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A; 2) TRUNK KIT 1EA, M
- Recall date
- 2026-03-04
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
Recommended action
What to do
10550 units
Product description
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.