Device product
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
Z-1406-2019
Product summary
- Firm
- Remel Inc
- Event
- Event 82683
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,069 units
- Official record key
device-enforcement:Z-1406-2019
Official wording
Reason: 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.
Code information: Material Number: R07182; Lot Number (Labeled Expiration Date): 309155 (12/12/2018), 329971 (01/17/2019), 346674 (02/26/2019), 354842 (03/07/2019), 376323 (04/18/2019), 398234 (06/06/2019), 404772 (06/13/2019).
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.