# FDA recall Z-1802-2018

> **Bard Peripheral Vascular Inc** · Class II · device recall initiated 2018-04-16.

## Product

BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.035", 150 cm, REF SK15035M.    Intended to support a guidewire during access into the vasculature.

## Reason for recall

Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the catheter is packaged in. The bacterial endotoxin levels for the catheters are within acceptable levels; however, if bacterial endotoxins are present on the packaging hoops it may have the potential for cross-contamination in a clinical setting.

## Distribution

Nationwide Distribution

## Key facts

- **Recall number:** Z-1802-2018
- **Recalling firm:** Bard Peripheral Vascular Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-16
- **Report date:** 2018-05-23
- **Termination date:** 2021-03-02

- **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-1802-2018

## Citation

> AI Analytics. FDA recall Z-1802-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1802-2018. Source: US FDA. Licensed CC0.

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