The Recall Desk
ModerateFDA (Devices)·Z-1377-2019·Announced 2019-05-29

Remel Thio Med w/Dex, Hem, Vit K Media Recalled for Performance Failure

Remel Inc is recalling 8,615 units of Thio Med w/Dex, Hem, Vit K media due to potential performance failures starting 57 days after manufacturing.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a performance failure of a laboratory medium rather than a direct physical injury or high-risk pathogen exposure, fitting the criteria for moderate severity.

Plain-English summary

Remel Inc is recalling 8,615 units of Thio Med w/Dex, Hem, Vit K (5ml) 100/PK. This product is a general-purpose media recommended for qualitative procedures to cultivate aerobes and anaerobes. The recall affects lots with expiration dates ranging from November 2018 to July 2019.

The recall is issued because the products have the potential to fail performance testing per the Instructions for Use (IFU) starting at 57 days after the date of manufacturing. Consequently, the expiration date for these products is shortened from 7 months to 56 days.

The affected products were distributed nationwide in the United States to numerous states and Puerto Rico, as well as internationally to Singapore. Users should check their inventory for the specific lot numbers listed in the recall notice and stop using any affected units.

The recalled product

Product
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
Manufacturer
Remel Inc
Category
Medical Device — Laboratory Media
Hazard
Affected units
8,615

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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)

Distribution

Distributed nationwide across the United States.

The notice also names 44 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Remel Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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