Recall Z-2001-2014
Vascular Technology, Inc. · initiated May 28, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
VTI BAYONET DOPPLER, 20MHz DOPPLER PROBE, SLIM, BX 4, REF 108660 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
Codes / lots: LOT NUMBER 11786-37683
Reason for recall
Report of the product penetrating the sterile barrier; this could render the product unsterile.
FDA-determined cause: Process design
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.
Details
- Recall number
- Z-2001-2014
- Initiated
- May 28, 2014
- Posted by FDA
- July 7, 2014
- Terminated
- February 11, 2016
- Product code
- DPW – Flowmeter, Blood, Cardiovascular
- Quantity
- 25
- Distribution
- Worldwide Distribution - US including California and the countries of Australia, United Kingdom and Taiwan.
- Recalling firm
- Vascular Technology, Inc., Nashua, NH
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1998-2014 Class II | 07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200 The Doppler probe is intended…Report of the product penetrating the sterile barrier; this could render the product unsterile. | 05/28/2014Terminated |
| Z-1999-2014 Class II | 07-150-10 MIZUHO, DOPPLER PROBE, SLIM, BX 4, REF 138660 The Doppler probe is intended…Report of the product penetrating the sterile barrier; this could render the product unsterile. | 05/28/2014Terminated |
| Z-2000-2014 Class II | 07-150-12 MIZUHO, MINI, SLIM, STERILE, BOX OF 4, REF 138665 The Doppler probe is…Report of the product penetrating the sterile barrier; this could render the product unsterile. | 05/28/2014Terminated |