Recall Z-3026-2018
Vascular Technology, Inc. · initiated June 19, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref. Number: 108910 Intraoperative (microvascular and vascular), Intraoperative Neurological, Transesophageal, Transrectal, Laparoscopic and Peripheral Vascular.
Codes / lots: Serial Numbers: 14329-001, 14329-002, 14329-003, 14329-004, 14329-005, 14329-006, 14329-007, 14329-008, 14329-009, and 14329-010.
Reason for recall
Device maybe mislabeled as a 20 MHz Doppler transceiver instead of an 8 MHz Doppler transceiver
FDA-determined cause: Labeling Change Control
Action taken
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.
Details
- Recall number
- Z-3026-2018
- Initiated
- June 19, 2018
- Terminated
- January 30, 2020
- Product code
- DPW – Flowmeter, Blood, Cardiovascular
- Quantity
- 10 units
- Distribution
- US Distribution to state of: CA.
- Recalling firm
- Vascular Technology, Inc., Nashua, NH