Recall Z-1379-2019— Remel Inc
Class II · Terminated
Class II FDA medical device recall by Remel Inc, initiated 2019-04-17, terminated 2020-08-21. FDA's recall record names no specific 510(k) clearance for this event. Product: Thio Med w/Dex, Hem, Vit K (7ml) 20/PK Product Usage; Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes. Reason: Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months to 56 days..
- Recalling firm
- Remel Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-04-17
- Terminated
- 2020-08-21
- Firm location
- Lenexa, KS, United States
Product description
Thio Med w/Dex, Hem, Vit K (7ml) 20/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 57 days after date of manufacturing. Expiration date is shortened from 7 months to 56 days.
Data sourced from openFDA. This site is unofficial and independent of the FDA.