Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intr
FDA device recall Z-1330-2025 · posted 2025-03-13 · Open, Classified
Recall details
- Recalling firm
- Cordis US Corp
- Reason for recall
- Catheter manufactured at the incorrect length.
- 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.
- Root cause
- Employee error
- Status
- Open, Classified
- Product code
- DQY
- Quantity affected
- 12 units
- Distribution
- US: WA OUS: Japan
- Date initiated
- 2025-02-07
- Date posted
- 2025-03-13
- Location
- Miami Lakes, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO ENVOY AND VISTA BRITE TIP (K021593) | Cordis Corp. | 2002-06-13 |