# FDA recall Z-2297-2021

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

## Product

DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system:  a) REF 3814773  b) REF 3835773  c) REF 3825773   d) REF 3837773  e) REF 3846773  f) REF 3831473  g) REF 3842473  h) REF 3821473  i) REF 3832473  j) REF 3833473  k) REF 3821573  l) REF 3831573  m) REF 3833573  n) REF 3824773  o) REF 3804773  p) REF 3845773  q) REF 3811473  r) REF 3836773  s) REF 3843473  t) REF 3800473  v) REF 3842573  w) REF 3832573  x) REF 3847773  y) REF 3800573

## 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-2297-2021
- **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-2297-2021

## Citation

> AI Analytics. FDA recall Z-2297-2021. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-2297-2021. Source: US FDA. Licensed CC0.

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