Recall Z-1198-2019— Cordis Corporation
Class III · Terminated
Class III FDA medical device recall by Cordis Corporation, initiated 2019-02-07, terminated 2021-11-03. It names 5 FDA 510(k) clearances: K143412, K021593, K992673 and 2 more. Product: Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.. Reason: Frayed pieces of the mounting card being inside the primary packaging..
- Recalling firm
- Cordis Corporation
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2019-02-07
- Terminated
- 2021-11-03
- Firm location
- Miami Lakes, FL, United States
510(k) clearances named in this recall
5 on FDA's record- K143412 — ADROIT Guiding Catheter
- K021593 — MODIFICATION TO ENVOY AND VISTA BRITE TIP
- K992673 — VISTA BRITE TIP CATHETERS
- K972978 — VISTA BRITE TIP GUIDING CATHETERS
- K963962 — VISTA BRITE TIP CATHETERS
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.
Reason for recall
Frayed pieces of the mounting card being inside the primary packaging.
Data sourced from openFDA. This site is unofficial and independent of the FDA.