ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMC
- Company
- Cordis Us Corp
- Recall Initiated
- March 24, 2023
- Posted
- May 11, 2023
- Recall Number
- Z-1485-2023
- Quantity
- 471 units
- Firm Location
- Miami Lakes, FL
Reason for Recall
There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared.
Distribution
Worldwide distribution.
Lot / Code Info
UDI/DI 20705032056745; Lot Numbers: 35263328, 35264207, 35264213, 35264216, 35265393, 35265648, 35265659
Root Cause
Vendor change control
Action Taken
The firm issued an Urgent MEDICAL DEVICE RECALL notice to it consignees on 03/24/2023 by letter. The notice explained the issue and the hazard, and requested the following actions be taken: - Check inventory and isolate the product to avoid use. - Complete and return the response form - Share this letter with others in your facility who need to be made aware of this recall and with any other facility that may have been sent the affected units of product from your facility. If any units of the affected lots are found to be at the other facility, please arrange the return of the units. - Return any affected product UPDATED 5/15/2023: The firm issued an updated letter dated 4/20/2023 since they extended the scope to include additional item and lot numbers, as well as removing some lot numbers. The remainder of the letter was similar to the initial letter dated 3/24/2023 and also contained a response form for return.