# FDA recall Z-1611-2023

> **TELEFLEX LLC** · Class II · device recall initiated 2023-04-12.

## Product

Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 4000; for sealing residual oozing of tissue tracts of femoral access sites that have been previously closed by suture/collagen-based hemostatic devices.

## Reason for recall

The product contains an expired diluent vial. If the impacted product is used, the sterility of the diluent component cannot be assured as it has passed beyond the studied shelf life of the product.

## Distribution

US Nationwide

## Key facts

- **Recall number:** Z-1611-2023
- **Recalling firm:** TELEFLEX LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-04-12
- **Report date:** 2023-05-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morrisville, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1611-2023

## Citation

> AI Analytics. FDA recall Z-1611-2023. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1611-2023. Source: US FDA. Licensed CC0.

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