Recall Z-0934-2020— 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 8 Fr., Part Number: 068400040310. It is an accessory to be used for percutaneous insertion of MAQUET IntraAortic 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 8 Fr., Part Number: 068400040310. It is an accessory to be used for percutaneous insertion of MAQUET IntraAortic 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.