Reinforced Introducer Sets Maquet 7.5 Fr., Part Number: 068400040305. It is an accessory to be used for percutaneous insertion of MAQUET IntraAortic Balloon Catheters.
Check against the official notice below — it lists the full affected range.
Datascope Corporation has recalled Reinforced Introducer Sets Maquet 7.5 Fr. (Part Number 068400040305) and related sizes (7 Fr. and 8 Fr.), which are accessories used for inserting MAQUET IntraAortic Balloon Catheters. The recall affects 676 units across nine specific lot codes due to the potential for compromised sterility in breached pouches. The affected products were distributed throughout the United States, Canada, and multiple countries in Europe, Africa, and Asia.
The recall covers lot codes 3000040290, 3000086802, 3000031711, 3000079613, 3000019781, 3000053099, 3000014728, 3000043100, and TTQ. The source document does not specify a remedy or recommended action for consumers who may have received these products.
Written by software from the official notice below. Not reviewed by a lawyer.
Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.
Reason for recall: Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs. Distribution: US: AK AL AZ CA CO CT FL GA IA ID IL IN KS KY LA MD MI MN MO MS NC ND NE NJ NY OH OK PA SC SD TN TX VA WA WI WV OUS: Switzerland, Netherlands, South Africa, Canada, Germany, Austria, Spain, Italy, Poland, Bharain, Malaysia Quantity: 676 Lot/code info: Part Number: 068400040305 UDI: 10607567106694 (068400040305) Lot Codes: 3000040290, 3000086802, 3000031711, 3000079613, 3000019781, 3000053099, 3000014728, 3000043100, TTQ.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.