PlainRecordsFDA · Medical device recall
Mynxgrip 5F… and 1 more product
- Date
- Jan. 17, 2024
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Ongoing
- Filed by
- Cordis US Corp
- 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.
- Distribution pattern
- US: NC, WV, TN, MS, MI, OH, CA
2 products in this recall
Mynxgrip 5F…
- Product
- MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites.
- Quantity
- 50 units
- Codes and lots
- UDI/DI 10862028000403, Lot numbers: F2322902
- Recall started
- Nov. 28, 2023
- Device type
- Device, Hemostasis, Vascular
- Root cause (FDA)
- Labeling Change Control
- What the company told customers
- Cordis issued an Urgent MEDICAL DEVICE RECALL notice to its consignees on 11/28/2023 via via FEDEX. The notice explained the issue and requested the return of any affected product in inventory. For questions related to the recall and/or acknowledgement form that are not adequately addressed in the letter, please contact Cordis QA at: GMB-CordisFieldAction@cordis.com or call Cordis Customer Support 1-800-327-7714 Option 2, Monday through Friday from 8:00 AM to 8:00 PM EDT.
- Recall number
- Z-0674-2024
Mynxgrip 6F/7F…
- Product
- MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites
- Quantity
- 70 units
- Codes and lots
- UDI/DI 10862028000403, Lot numbers: F2322903
- Recall started
- Nov. 28, 2023
- Device type
- Device, Hemostasis, Vascular
- Root cause (FDA)
- Labeling Change Control
- What the company told customers
- Cordis issued an Urgent MEDICAL DEVICE RECALL notice to its consignees on 11/28/2023 via via FEDEX. The notice explained the issue and requested the return of any affected product in inventory. For questions related to the recall and/or acknowledgement form that are not adequately addressed in the letter, please contact Cordis QA at: GMB-CordisFieldAction@cordis.com or call Cordis Customer Support 1-800-327-7714 Option 2, Monday through Friday from 8:00 AM to 8:00 PM EDT.
- Recall number
- Z-0675-2024
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-0674-2024, Z-0675-2024. The agency record governs; check it and the company before acting.