# K112666: Saline Wound Wash

- Pathway: 510(k) (Traditional)
- Applicant: Nanoplas, Inc.
- Decided: Apr 20, 2012 after 220 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Jan 5, 2026 · Class II · Z-1431-2026: 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.
- Jan 5, 2026 · Class II · Z-1432-2026: 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.
- Jan 5, 2026 · Class II · Z-1435-2026: 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.
- Jan 5, 2026 · Class II · Z-1433-2026: 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.
- Jan 5, 2026 · Class II · Z-1434-2026: 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.

Source page: https://510kreport.com/device/K112666
Methodology: https://510kreport.com/methodology