Reinforced Introducer Sets Maquet 7 Fr., Part Number: 0684 00 0403 06. It is an accessory to be used for percutaneous insertion of MAQUET Intra Aortic Balloon Catheters.
Check against the official notice below — it lists the full affected range.
Datascope Corporation has recalled 102 units of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. (Part Number: 0684 00 0403 06) due to potential compromised sterility in breached pouches of specific lots. These sets are accessories used for percutaneous insertion of MAQUET Intra Aortic Balloon Catheters. The affected products have Lot Codes 3000051658 and TLT and were distributed throughout the United States, as well as to Switzerland, Netherlands, South Africa, Canada, Germany, Austria, Spain, Italy, Poland, Bahrain, and Malaysia.
The source document does not specify a remedy 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: 102 Lot/code info: Part Number: 0684 00 0403 06 UDI: 10607567106656 (0684 00 0403 06) Lot Codes: 3000051658, TLT
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.