# FDA recall Z-2302-2021

> **Delta Med SpA** · Class II · device recall initiated 2021-06-21.

## Product

NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122

## Reason for recall

Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

## Distribution

US Nationwide distribution in the states of FL and MN.

## Key facts

- **Recall number:** Z-2302-2021
- **Recalling firm:** Delta Med SpA
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-06-21
- **Report date:** 2021-08-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Viadana, N/A, Italy

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2302-2021

## Citation

> AI Analytics. FDA recall Z-2302-2021. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-2302-2021. Source: US FDA. Licensed CC0.

---

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