Recall Z-0932-2020 ยท DSP System, Balloon, Intra-Aortic And Control
Datascope Corporation
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.
| Date | Nov 20, 2019 |
| Status | Terminated |
| 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. |
| Root cause | Package design/selection |
| Action | On December 11, 2019 the firm distributed Urgent Medical Device Recall Communication letters by FedEx 2 day delivery with signature proof of delivery stating: URGENT MEDICAL DEVICE RECALL REMOVAL MAQUET 7Fr., 7.5Fr. and 8Fr. REINFORCED INTRODUCER SETS PLEASE FORWARD THIS INFORMATION TO ALL CURRENT AND POTENTIAL USERS OF REINFORCED INTRODUCER SETS FOR MAQUET 7 Fr., 7.5 Fr. AND 8 Fr. INTRA-AORTIC BALLOON (IAB) WITHIN YOUR HOSPITAL OR FACILITY. IF YOU HAVE FURTHER DISTRIBUTED ANY OF THE AFFECTED PRODUCTS, FORWARD THIS INFORMATION TO THE RECIPIENT. Dear Risk Manager, Datascope / Maquet |
| Quantity | 102 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.