07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200 The Doppler probe is intended for the intraoperative and trans
FDA device recall Z-1998-2014 · posted 2014-07-07 · Terminated
Recall details
- Recalling firm
- Vascular Technology, Inc.
- Reason for recall
- Report of the product penetrating the sterile barrier; this could render the product unsterile.
- Action taken
- 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, please identify your customers and notify them at once of this product recall. Your notification to your customer must include instructions telling your customer to return the recalled product if unused or to account for the recalled product if it has been used. For further questions please call (603) 594-9700.
- Root cause
- Process design
- Status
- Terminated
- Product code
- DPW
- Quantity affected
- 164
- Distribution
- Worldwide Distribution - US including California and the countries of Australia, United Kingdom and Taiwan.
- Date initiated
- 2014-05-28
- Date posted
- 2014-07-07
- Date terminated
- 2016-02-11
- Location
- Nashua, NH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VTI INTRAOPERATIVE DOPPLER SYSTEMS (K082870) | Vascular Technology Incorporated | 2008-10-28 |