Z-1966-2019 Class II Terminated
FDA device recall Z-1966-2019 was initiated by Datascope Corporation on May 28, 2019 and is designated Class II. Reason for recall: The device was distributed with the outer carton labeled with the manufacture date and the expiry date reversed. This showed the product as expired before it was manufactured. The recall status is terminated (terminated September 25, 2023). Affected quantity: 471.
Recall Details
- Product Type
- Devices
- Report Date
- July 24, 2019
- Initiation Date
- May 28, 2019
- Termination Date
- September 25, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 471
Product Description
Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part Number 0684-00-0568-01 Product Usage: The Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories is a device that includes a catheter, an insertion kit and two STATLOCK IAB stabilization devices. It is a cardiac assist device intended to provide counterpulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.
Reason for Recall
The device was distributed with the outer carton labeled with the manufacture date and the expiry date reversed. This showed the product as expired before it was manufactured.
Distribution Pattern
The products were distributed to the following US states: FL. The products were distributed to the following foreign countries: Australia, Austria, Belgium, Estonia, France, Germany, Ireland, Italy, Kuwait, Lithuania, Malaysia, Mexico, Netherlands, Poland, Russia, Saudi Arabia, Slovakia, Sweden, Switzerland, United Kingdom, Ukraine.
Code Information
UDI Code: 10607567108063; Lot Codes: 3000082472, 3000084069, 3000085231, 3000086994, 3000087688, 3000091205, 3000091206, 3000091828