Recall Z-1330-2025
Cordis US Corp · initiated February 7, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.
Codes / lots: UDI: 20705032042991/ Lot Number: 18368326
Reason for recall
Catheter manufactured at the incorrect length.
FDA-determined cause: Employee error
Action taken
On February 7, 2025 Cordis issued a Urgent Medical Device Recall notification to affected consignees via E-Mail. Cordis asked consignees to take the following actions: 1) Read this Urgent Medical Device Recall letter. 2) Immediately check your inventory for any units from the affected lot in your possession. 3. Identify and quarantine any units. Check all storage and usage locations. 3) Share this letter with others in your facility who need to be made aware of this recall and with any other facility. 4) Review, complete, sign and return the enclosed Acknowledgement Form directly to Cordis at the fax number on the form or email to: GMB-CordisFieldAction@cordis.com 5) Return any affected product to the address listed on the form, with reference to your Customer Number which is listed on the form. 6) Maintain awareness of this notice until all affected product has been returned to Cordis and keep a copy of this notice with the affected product.
Details
- Recall number
- Z-1330-2025
- Initiated
- February 7, 2025
- Posted by FDA
- March 13, 2025
- Product code
- DQY – Catheter, Percutaneous
- Quantity
- 12 units
- Distribution
- US: WA OUS: Japan
- Recalling firm
- Cordis US Corp, Miami Lakes, FL