FDAClass IIMay 29, 2019

Thio Med w/Dex recall

Thio Med w/Dex, Hemin, Vit K (5ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation…

Why was Thio Med w/Dex recalled?

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.

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?

Lot Number (Expiration Date): 328725 (01/16/2019), 345633 (02/20/2019), 346706 (02/27/2019), 385229 (05/07/2019), 396646 (05/30/2019), 399823 (06/11/2019).

Product
Thio Med w/Dex, Hemin, Vit K (5ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation…
Recalling firm
Remel Inc
Quantity
1,205 units
Distribution
Worldwide Distribution -US Nationwide distribution to AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, VA, VT, WA, WI, WV, WY, Puerto Rico. International distribution to Singapore
Recall date
May 29, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls