Recall Z-3026-2018 ยท DPW Flowmeter, Blood, Cardiovascular
Vascular Technology, Inc.
VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref. Number: 108910 Intraoperative (microvascular and vascular), Intraoperative Neurological, Transesophageal, Transrectal, Laparoscopic and Peripheral Vascular.
| Date | Jun 19, 2018 |
| Status | Terminated |
| Reason | Device maybe mislabeled as a 20 MHz Doppler transceiver instead of an 8 MHz Doppler transceiver |
| Root cause | Labeling Change Control |
| Action | The firm, Vascular Technology, Inc., "URGENT: MEDICAL RECALL DEVICE" letter dated June 18, 2018, to its customer on June 19, 2018. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine inventory and return all product subject to recall. In addition, if you have further distributed this product, please identify your customers and notify them at once of this product recall. If you have any questions, contact VP Sales person at 603-594-9700. |
| Quantity | 10 units |
| Distribution | US Distribution to state of: CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031091 | VTI 20 MHZ GATED DOPPLER Vascular Technology Incorporated, Apr 23, 2003 |