Recall Z-0932-2020— Datascope Corporation
Class II · Terminated
Class II FDA medical device recall by Datascope Corporation, initiated 2019-11-20, terminated 2021-06-15. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Datascope Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-11-20
- Terminated
- 2021-06-15
- Firm location
- Fairfield, NJ, United States
Product 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 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.