Lower risk Medical device recall · FDA · Published April 17, 2019

Remel Thio Med w/Dex, Hem, Vit K (5ml) 100/PK: Shortened Expiry Risk

Remel recalls Thio Med w/Dex, Hem, Vit K (5ml) 100/PK products with shortened expiry dates due to potential failure in performance testing after 57 days.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1377-2019Medical device Remel ›

Lower-risk 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.

Take action

Contact the company

Recalling firmRemel Inc12076 Santa Fe Trail Dr · Lenexa, KS 66215-3519

✎ GovInfoNow plain-language explainer

Remel is recalling Thio Med w/Dex, Hem, Vit K (5ml) 100/PK products that may fail performance testing after 57 days. This affects products with specific lot numbers and shortened expiration dates from 7 months to 56 days. Read more at govinfonow.com/recall/68317-remel-thio-med-w-dex-hem-vit-k-5ml-100.

Source Summary by GovInfoNow · govinfonow.com/recall/68317-remel-thio-med-w-dex-hem-vit-k-5ml-100 · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1377-2019

Cite this page

“Remel Thio Med w/Dex, Hem, Vit K (5ml) 100/PK: Shortened Expiry Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68317-remel-thio-med-w-dex-hem-vit-k-5ml-100. Based on FDA recall #Z-1377-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1377-2019%22&limit=1).

The FDA announced on April 17, 2019, that Remel Inc is recalling Thio Med w/Dex, Hem, Vit K (5ml) 100/PK products. The agency cited potential failure to meet performance testing standards as the hazard. Owners should check lot numbers against the recall list.

How to tell if you have it

Brand: Remel
Product: Thio Med w/Dex, Hem, Vit K (5ml) 100/PK Product Usage
Lot Numbers: 298222, 298278, 309142, 314202, 318109, 321247, 321615, 322654, 323445, 323457, 325888, 325891, 327637, 328656, 328730, 331413, 332316, 333823, 334609, 335243, 336083, 337937, 340117, 340303, 340777, 341993, 343924, 344723, 344727, 345317, 345632, 345635, 346533, 346643, 346668, 346710, 347381, 356316, 357251, 357252, 359078, 359887, 360823, 360813, 362019, 366795, 366791, 367418, 370206, 371226, 372100, 373087, 373799, 376324, 377039, 377642, 378521, 379725, 380472, 381210, 381231, 382455, 384276, 385228, 386110, 388169, 390399, 393235, 395637, 396586, 396645, 397090, 397589, 397583, 398225, 399822, 409550, 412073, 413484, 413493, 470812
Units affected: 8,615

The hazard

The products may fail performance testing per the Instructions for Use starting at 57 days after the date of manufacturing. Consequently, the expiration date is shortened from 7 months to 56 days.

Context

GovInfoNow's records show Remel, Inc has 22 other recalls on record since November 2, 2017. Other recent recalls include a June 3, 2026 recall of Remel GC Agar Base for reduced Neisseria gonorrhoeae recovery risk and a March 24, 2026 recall of Remel Yeastone Broth for incorrect lab results risk. Similar recent recalls of similar products include Cook Medical's March 5, 2026 recalls of the Spectrum Central Venous Tray, Staged Extubation Set, and Thal-Quick Chest Tube Tray for expiration dates exceeding shelf life.

How to tell if you have this one

Check for lot numbers listed in the recall: 298222 (11/22/2018), 298278 (11/26/2018), and other specific dates. The product is used for growing bacteria in labs and medical testing.

Brand
Remel
Category
Medical device

FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
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 number	Product, codes & lots	Quantity
Z-1377-2019	Thio 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; 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).	8,615 units
Z-1378-2019	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 of aerobes and anaerobes; 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).	1,205 units
Z-1379-2019	Thio Med w/Dex, Hem, Vit K (7ml) 20/PK Product Usage; Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes; Lot Number (Expiration Date): 303285 (09/27/2018), 309151 (10/10/2018), 353575 (01/02/2019).	133 units
Z-1380-2019	Thio Med w/Dex, Hem, Vit, K (7ml) 100/PK Product Usage; Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes; Lot Number (Expiration Date): 309152 (10/10/2018), 337708 (12/03/2018), 353574 (01/02/2019), 378524 (02/20/2019).	242 units

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Look for the lot number on the product label to see if it matches the listed numbers in the recall.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 43 states.

FDA 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.…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA terminated this recall 16 months after the firm started it.

Apr 17, 2019Firm started the recall
May 20, 2019FDA classified it Class II
May 29, 2019Published in FDA’s Enforcement Report
Aug 21, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

How can I tell if I have a recalled product?

Check the lot number on the product label against the list of specific lot numbers provided in the recall notice.

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Link to this recall

<a href="https://govinfonow.com/recall/68317-remel-thio-med-w-dex-hem-vit-k-5ml-100">Remel Thio Med w/Dex, Hem, Vit K (5ml) 100/PK: Shortened Expiry Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1377-2019 (April 17, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1377-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.