# FDA recall Z-2489-2020

> **Prodimed Plastimed Division** · Class II · device recall initiated 2020-05-27.

## Product

Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH 90 cm x 1.9 mm  Product Code: 58229 19US

## Reason for recall

Lack of assurance of sterility

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-2489-2020
- **Recalling firm:** Prodimed Plastimed Division
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-05-27
- **Report date:** 2020-07-15
- **Termination date:** 2021-03-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Le Plessis Bouchard, France

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2489-2020

## Citation

> AI Analytics. FDA recall Z-2489-2020. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2489-2020. Source: US FDA. Licensed CC0.

---

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