Thio Med w/o Ind recall
Thio Med w/o Ind, w/Dex (10ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of…
Why was Thio Med w/o Ind 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Material Number: R08852; Lot Number (Labeled Expiration Date): 307916 (12/11/2018), 337081 (01/31/2019), 359857 (03/19/2019), 381201 (04/30/2019). Expansion Lot Number (Labeled Expiration Date): 423518 (07/30/2019). Material Number: R07178; Lot Number (Labeled Expiration Date): 311677 (12/18/2018), 347391 (02/28/2019), 366062 (03/28/2019), 390570 (05/16/2019), 396653 (05/30/2019), 417781 (07/17/2019).
- Product
- Thio Med w/o Ind, w/Dex (10ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of…
- Recalling firm
- Remel Inc
- Quantity
- 282 units
- 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.
- Recall date
- May 29, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)