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U.S. Department of Health and Human Services

Class 2 Device Recall Thio Med w/Dex, Hem, Vit K (5ml) 100/PK

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 Class 2 Device Recall Thio Med w/Dex, Hem, Vit K (5ml) 100/PKsee related information
Date Initiated by FirmApril 17, 2019
Create DateMay 20, 2019
Recall Status1 Terminated 3 on August 21, 2020
Recall NumberZ-1377-2019
Recall Event ID 82677
Product Classification Culture media, non-selective and non-differential - Product Code JSG
ProductThio Med w/Dex, Hem, Vit K (5ml) 100/PK Product Usage; Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
Code Information Lot Number (Expiration Date): 298222 (11/22/2018), 298278 (11/26/2018), 309142 (12/12/2018), 314202 (12/20/2018), 318109 (12/27/2018), 321247 (01/02/2019), 321615 (01/03/2019), 322654 (01/07/2019), 323445 (01/08/2019), 323457 (01/08/2019), 325888 (01/10/2019), 325891 (01/10/2019), 327637 (01/15/2019), 328656 (01/16/2019), 328730 (01/16/2019), 331413 (01/22/2019), 332316 (01/23/2019), 333823 (01/24/2019), 334609 (01/28/2019), 335243 (01/29/2019), 336083 (01/30/2019), 337937 (02/05/2019), 340117 (02/07/2019), 340303 (02/07/2019), 340777 (02/11/2019), 341993 (02/12/2019), 343924 (02/14/2019), 344723 (02/18/2019), 344727 (02/18/2019), 345317 (02/19/2019), 345632 (02/20/2019), 345635 (02/20/2019), 346533 (02/21/2019), 346643 (02/21/2019), 346668 (02/26/2019), 346710 (02/27/2019), 347381 (02/28/2019), 356316 (03/12/2019), 357251 (03/13/2019), 357252 (03/13/2019), 359078 (03/18/2019), 359887 (03/19/2019), 360823 (03/20/2019), 360813 (03/20/2019), 362019 (03/21/2019), 366795 (04/01/2019), 366791 (04/01/2019), 367418 (04/02/2019), 370206 (04/09/2019), 371226 (04/10/2019), 372100 (04/11/2019), 373087 (04/15/2019), 373799 (04/16/2019), 376324 (04/18/2019), 377039 (04/22/2019), 377642 (04/23/2019), 378521 (04/24/2019), 379725 (04/25/2019), 380472 (04/29/2019), 381210 (04/30/2019), 381231 (05/01/2019), 382455 (05/02/2019), 384276 (05/06/2019), 385228 (05/07/2019), 386110 (05/08/2019), 388169 (05/13/2019), 390399 (05/16/2019), 393235 (05/22/2019), 395637 (05/27/2019), 396586 (05/29/2019), 396645 (05/30/2019), 397090 (06/04/2019), 397589 (06/05/2019), 397583 (06/05/2019), 398225 (06/06/2019), 399822 (06/11/2019), 409550 (06/26/2019), 412073 (06/28/2019), 413484 (07/04/2019), 413493 (11/29/2018), 470812 (05/07/2019).  
FEI Number 1924669
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 57 days after date of manufacturing. Expiration date is shortened from 7 months to 56 days.
FDA Determined
Cause 2		Under Investigation by firm
ActionThermo Fisher Scientifica/ 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. Questions or concerns can be directed to Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International).
Quantity in Commerce8,615 units
DistributionWorldwide 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
Total Product Life CycleTPLC 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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