Recall Z-0785-2017— 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 Sterile Disposable Probes sold individually. 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 Sterile Disposable Probes sold individually
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.