# FDA recall Z-3062-2024

> **Bard Peripheral Vascular Inc** · Class II · device recall initiated 2024-07-10.

## Product

Guidewire 70cm x 1mm (0.038 ) REF 5583705    These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lumen  Hemodialysis Catheters. Please refer to the applicable catheter Instructions for Use for  directions on the use of these accessories.

## Reason for recall

Due to guidewires being manufactured incorrectly with the guidewires being mis-assembled within the hoop such that the proximal (stiff) end of the  guidewire is located at the distal end of the hoop. Injury could occur if the user attempts to insert the proximal end into the patient.

## Distribution

Worldwide - U.S. Nationwide distribution in the states of OH, TX, and WV. The countries of  Belgium, Canada, France, Italy, and United Kingdom.

## Key facts

- **Recall number:** Z-3062-2024
- **Recalling firm:** Bard Peripheral Vascular Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-07-10
- **Report date:** 2024-09-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tempe, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3062-2024

## Citation

> AI Analytics. FDA recall Z-3062-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-3062-2024. Source: US FDA. Licensed CC0.

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