Recall Z-0784-2017 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Ultroid Technologies, Inc.
Ultroid Procedure Pack including the Ultroid Sterile Disposable Probes.
| Date | Oct 19, 2016 |
| Status | Terminated |
| 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) |
| Root cause | Process control |
| Action | On October 19, 2016 Ultrid sent a recall letter to all their consignees informing them of the recall and to cease further distribution of this product, respond the self-addressed response form and returned for a voucher. For more information contact Melanie Rosario at 727-898-0717 |
| Quantity | 52,084 |
| Distribution | AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, KS, LA, MD, ME, MI, MN, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA and Puerto Rico Asturias, Australia, Chile, Greece, Hong Kong, India, Indonesia, Iraq, Japan, Kuwait, Malaysia, Mexico, Nigeria, Qatar, Russia, Slovenia, Spain, Syria, T |
| FDA record | Open on fda.gov |