Z-1406-2019Class II

Thio Med w/Dex, Hem, Vit K (10ml) 20/PK

Name: Z-1406-2019 Thio Med w/Dex, Hem, Vit K (10ml) 20/PK
Creator: Remel Inc
Published: 2019-04-17
License: https://open.fda.gov/license/

Remel Inc / initiated 2019-04-17 / Terminated / root cause: labeling and UDI

FDA source

Remel Inc began a recall of 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... on 2019-04-17. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1406-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-17
Posted: 2019-05-22
Terminated: 2020-07-10
Recalling firm: Remel Inc
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
Product code: JSG Culture Media, Non-Selective And Non-Differential
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.
Root cause tag: labeling and UDI
FDA root cause: 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: 1,069 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.
Product codes and lots: 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).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1406-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1400-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-29	2019-05-22
Z-1401-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-29	2019-05-22
Z-1402-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-29	2019-05-22
Z-1403-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-29	2019-05-22
Z-1404-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-29	2019-05-22
Z-1405-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-29	2019-05-22
Z-1406-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-29	2019-05-22
Z-1407-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-29	2019-05-22
Z-1408-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-29	2019-05-22
Z-1409-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-29	2019-05-22

Product code JSG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)