FDA Enforcement
Class II
Terminated
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.
Recall: Z-0932-2020
·
Reported February 12, 2020
Enforcement
- Recall Number
- Z-0932-2020
- Event ID
- 84521
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Datascope Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 12, 2020
- Initiation Date
- November 20, 2019
- Classification Date
- February 1, 2020
- Termination Date
- June 15, 2021
- Address
- 15 Law Dr, N/A, Fairfield, NJ, 07004-3206, United States
Description
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.
Reason
Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.
Code Info
Part Number: 0684 00 0403 06 UDI: 10607567106656 (0684 00 0403 06) Lot Codes: 3000051658, TLT
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