Datascope Corporation: 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 Cathete

Is my product affected?

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

• UPC 10607567108063

Check against the official notice below — it lists the full affected range.

What happened

Datascope Corporation recalled 471 units of the Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories (Part Number 0684-00-0568-01) because the outer carton labeling had the manufacture date and expiry date reversed, making the products appear expired before they were manufactured. The affected devices were distributed to Florida and to multiple countries including Australia, Austria, Belgium, Estonia, France, Germany, Ireland, Italy, Kuwait, Lithuania, Malaysia, Mexico, Netherlands, Poland, Russia, Saudi Arabia, Slovakia, Sweden, Switzerland, United Kingdom, and Ukraine, across eight lot codes.

The recall record does not specify a remedy or recommended action for consumers who may have this product.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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: 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. Quantity: 471 Lot/code info: UDI Code: 10607567108063; Lot Codes: 3000082472, 3000084069, 3000085231, 3000086994, 3000087688, 3000091205, 3000091206, 3000091828

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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