Recall Z-0782-2017— Ultroid Technologies, Inc.
Class II · Terminated
Class II FDA medical device recall by Ultroid Technologies, Inc., initiated 2016-10-19, terminated 2019-12-11. It names 2 FDA 510(k) clearances: K030315, K023706. Product: Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the Ultroid Disposable Sterile Probes. Reason: Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws, regulations, directives, standards, and/or guidance (such as 21 CFR 820 Quality System Regulation).
- Recalling firm
- Ultroid Technologies, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-10-19
- Terminated
- 2019-12-11
- Firm location
- Tampa, FL, United States
510(k) clearances named in this recall
2 on FDA's record- K030315 — MODIFICATION TO ULTROID HEMORRHOID MANAGEMENT SYSTEM
- K023706 — ULTROID HEMORRHOID MANAGEMENT SYSTEM
K-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
Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the Ultroid Disposable Sterile Probes
Reason for recall
Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws, regulations, directives, standards, and/or guidance (such as 21 CFR 820 Quality System Regulation)
Data sourced from openFDA. This site is unofficial and independent of the FDA.