Recall Z-0674-2024— Cordis US Corp
Class II · Ongoing
Class II FDA medical device recall by Cordis US Corp, initiated 2023-11-28. FDA's recall record names no specific 510(k) clearance for this event. Product: MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites.. Reason: Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. The carton box from lot F2322902 (Item MX5021, MynxGrip 5F) as labeled as lot F2322903 (MX6721, MynxGrip 6/7F) and product from lot F2322903 (MX6721, MynxGrip 6/7F) was labeled as F2322902 (Item MX5021, MynxGrip 5F). The primary label on individual devices is correct..
- Recalling firm
- Cordis US Corp
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-11-28
- Firm location
- Miami Lakes, FL, United States
Product description
MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites.
Reason for recall
Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. The carton box from lot F2322902 (Item MX5021, MynxGrip 5F) as labeled as lot F2322903 (MX6721, MynxGrip 6/7F) and product from lot F2322903 (MX6721, MynxGrip 6/7F) was labeled as F2322902 (Item MX5021, MynxGrip 5F). The primary label on individual devices is correct.
Data sourced from openFDA. This site is unofficial and independent of the FDA.