Reinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310. 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 8 Fr. (Part Number 068400040310) used as accessories for inserting MAQUET IntraAortic Balloon Catheters. The recall affects 523 units distributed across the United States, Canada, and several European and international locations due to potential compromised sterility in breached pouches of specific lots, including lot codes 3000079612, 3000043101, 3000036631, 3000015016, and TTP.
The record does not specify a remedy or recommended action for affected consumers.
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: 523 Lot/code info: Part Number: 068400040310 UDI: 10607567107943 (068400040310) Lot Codes: 3000079612, 3000043101, 3000036631, 3000015016, TTP.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.