Recall Z-2000-2014 ยท DPW Flowmeter, Blood, Cardiovascular
Vascular Technology, Inc.
07-150-12 MIZUHO, MINI, SLIM, STERILE, BOX OF 4, REF 138665 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
| Date | Jul 7, 2014 (initiated May 28, 2014) |
| Status | Terminated |
| Reason | Report of the product penetrating the sterile barrier; this could render the product unsterile. |
| Root cause | Process design |
| Action | Vascular Technology sent an Urgent Medical Device Recall letter dated May 28, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This recall has been initiated due to a report of the product penetrating the sterile barrier; this could render the product unsterile. Use of this product may lead to infection in the patient. Please immediately examine your inventory and return all product subject to recall to Vascular Technology at the above mentioned address. In addition, if you have further distributed this product, |
| Quantity | 34 |
| Distribution | Worldwide Distribution - US including California and the countries of Australia, United Kingdom and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082870 | VTI INTRAOPERATIVE DOPPLER SYSTEMS Vascular Technology Incorporated, Oct 28, 2008 |