# FDA recall Z-2068-2019

> **Epimed International, Inc.** · Class II · device recall initiated 2019-06-18.

## Product

Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED,  REF 181-2112, RX,  (01) 108187880213945, LOT 311291155   for  epidural or caudal anesthesia

## Reason for recall

Mislabeled - The product's labeling contains an incorrect size for the catheter included in the kit.  The kit contains a 21 gauge catheter, however the labeling states a 12 gauge catheter is included.

## Distribution

Distribution in US states of CA, FL, OK, AR, WA, TX, ID, NY, South Africa, and Mexico

## Key facts

- **Recall number:** Z-2068-2019
- **Recalling firm:** Epimed International, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-06-18
- **Report date:** 2019-07-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Johnstown, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2068-2019

## Citation

> AI Analytics. FDA recall Z-2068-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2068-2019. Source: US FDA. Licensed CC0.

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