Z-1687-2022 Class II Ongoing
FDA device recall Z-1687-2022 was initiated by Datascope Corporation on August 5, 2022 and is designated Class II. Reason for recall: Certain lots containing undersized dilator. The recall status is ongoing. Affected quantity: 10,427 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 14, 2022
- Initiation Date
- August 5, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,427 units
Product Description
Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter
Reason for Recall
Certain lots containing undersized dilator.
Distribution Pattern
Awaiting domestic distribution. Foreign: Australia, Belgium, Canada, Czech Republic, France, Germany, Hong Kong, Iceland, Ireland, Italy, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
Code Information
Code information reads "UDI-DI, Lot No., Finished Goods Part No.": 10607567108599, 3000170709, 0884-00-0019-23; 10607567108599, 3000182611, 0884-00-0019-23; 10607567108599, 3000202083, 0884-00-0019-23