# FDA recall Z-1408-2019

> **Remel Inc** · Class II · device recall initiated 2019-04-17.

## Product

Thio Med w/o Ind, w/Dex (18ml) 100/PK    Product Usage:  Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes

## Reason for recall

Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after  date of manufacturing. Expiration date is shortened from 9 months to 105 days.

## Distribution

Worldwide Distribution -US Nationwide to AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico.  International distribution to Canada.

## Key facts

- **Recall number:** Z-1408-2019
- **Recalling firm:** Remel Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-17
- **Report date:** 2019-05-29
- **Termination date:** 2020-07-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lenexa, KS, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1408-2019

## Citation

> AI Analytics. FDA recall Z-1408-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1408-2019. Source: US FDA. Licensed CC0.

---

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