Recall Z-0030-2022— Contamac Solutions, Inc.
Class II · Terminated
Class II FDA medical device recall by Contamac Solutions, Inc., initiated 2021-07-27, terminated 2023-06-07. It names one FDA 510(k) clearance: K181566. Product: Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free, 35 Single-use 10ml ampoules (360ml), UDI:00850012123002. Reason: Contact lens solution may contain foreign material.
- Recalling firm
- Contamac Solutions, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-07-27
- Terminated
- 2023-06-07
- Firm location
- Grand Junction, CO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free, 35 Single-use 10ml ampoules (360ml), UDI:00850012123002
Reason for recall
Contact lens solution may contain foreign material
Data sourced from openFDA. This site is unofficial and independent of the FDA.