Z-0725-2018 Class II Terminated
FDA device recall Z-0725-2018 was initiated by Terumo Medical Corporation on September 12, 2017 and is designated Class II. Reason for recall: The tucking depth feature of this catheter introducer is marginally outside the upper specification. The recall status is terminated (terminated August 31, 2018). Affected quantity: 33.
Recall Details
- Product Type
- Devices
- Report Date
- March 7, 2018
- Initiation Date
- September 12, 2017
- Termination Date
- August 31, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33
Product Description
Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destination¿ Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal, carotid, and peripheral arteries.
Reason for Recall
The tucking depth feature of this catheter introducer is marginally outside the upper specification.
Distribution Pattern
To be added.
Code Information
Lot: VK09, Expiration Date: 31-Jan-2020