# FDA recall Z-1828-2022

> **Cook Incorporated** · Class II · device recall initiated 2022-08-16.

## Product

Coons Interventional Wire Guide, Guidewire;  Reference Part Number/GPN:  THSF-35-145-COONS	G02356  THSF-38-145-COONS	G02324  THSF-35-180-COONS	G02621  THSF-35-80-COONS	G12268

## Reason for recall

Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

## Distribution

Domestic distribution nationwide. Foreign distribution worldwide.

## Key facts

- **Recall number:** Z-1828-2022
- **Recalling firm:** Cook Incorporated
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-08-16
- **Report date:** 2022-10-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bloomington, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1828-2022

## Citation

> AI Analytics. FDA recall Z-1828-2022. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/Z-1828-2022. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*