Z-1770-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 29, 2020
- Initiation Date
- February 25, 2020
- Termination Date
- April 27, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30 units
Product Description
Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle, REF: 122852, Sterile EO, RxOnly
Reason for Recall
It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay to pulmonary embolism.
Distribution Pattern
US: CA,SC, AZ OUS: None
Code Information
Affected Lot Numbers/Expiration Date: 19052006/ May 2020 19061318/ June 2020