# FDA recall Z-0675-2024

> **Cordis US Corp** · Class II · device recall initiated 2023-11-28.

## Product

MYNXGRIP 6F/7F, REF MX6721, 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.

## Distribution

US:  NC, WV, TN, MS, MI, OH, CA

## Key facts

- **Recall number:** Z-0675-2024
- **Recalling firm:** Cordis US Corp
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-28
- **Report date:** 2024-01-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Miami Lakes, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0675-2024

## Citation

> AI Analytics. FDA recall Z-0675-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0675-2024. Source: US FDA. Licensed CC0.

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