Recall record at a glance
| Official record | Z-1406-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Remel Inc. |
| Report date | May 29, 2019 |
| Recall initiation date | Apr 17, 2019 |
| Quantity | 1,069 units |
| Location | Lenexa, KS, United States |
Official product description
Thio Med w/Dex, Hem, Vit K (10ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
Why the product was recalled
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 information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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