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U.S. Department of Health and Human Services

Class 2 Device Recall Thio Med w/o Ind, w/Dex (18ml) 100/PK

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  Class 2 Device Recall Thio Med w/o Ind, w/Dex (18ml) 100/PK see related information
Date Initiated by Firm April 17, 2019
Create Date May 22, 2019
Recall Status1 Terminated 3 on July 10, 2020
Recall Number Z-1408-2019
Recall Event ID 82683
Product Classification Culture media, non-selective and non-differential - Product Code JSG
Product Thio Med w/o Ind, w/Dex (18ml) 100/PK

Product Usage:
Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
Code Information Material Number: R08856; Lot Number (Labeled Expiration Date): 314864 (12/24/2018), 343867 (02/14/2019), 367396 (04/02/2019), 387017 (05/09/2019). Expansion Lot Number (Labeled Expiration Date): 423518 (07/30/2019).
Recalling Firm/
Manufacturer		 Remel Inc
12076 Santa Fe Trail Dr
Lenexa KS 66215-3519
For Additional Information Contact
800-255-6730
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Under Investigation by firm
Action Thermo Fisher Scientific/ Remel notified consignees on about 04/17/2019 via " URGENT MEDICAL DEVICE FIELD ACTION RECALL" letter. Instructions included to locate all affected in inventory, destroy any affected product identified, contact Customer Services or local distributor to arrange for replacements, notify all customers if product was further distributed, and complete and return the Field Action Response form. Customers were also instructed that the requirement for review of reported test results using product beyond the updated expiry date should be determined by the appropriate technical expert at each customer location. Thermo Fisher Scientific/Remel expanded the recall and notified consignees on about 05/08/2019 via "URGENT MEDICAL DEVICE FIELD ACTION RECALL AMENDED NOTICE: ADDITIONAL IMPACTED LOTS" letter. The letter contained the same instructions as the initial letter, but the updated letter provided the additional impacted lots and requested that consignees respond again confirming receipt and understanding of the expansion. Questions or concerns can be directed to Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International).
Quantity in Commerce 76 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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