The Recall Desk
ModerateFDA (Devices)·Z-1378-2019·Announced 2019-05-29

Remel Inc Recalls Thio Med w/Dex, Hemin, Vit K Media

Remel Inc is recalling Thio Med w/Dex, Hemin, Vit K media because the products may fail performance testing after 57 days.

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, which typically corresponds to a moderate severity score when no specific injuries or illnesses are reported in the source text.

Plain-English summary

Remel Inc is recalling 1,205 units of Thio Med w/Dex, Hemin, Vit K (5ml) 20/PK. The product is a general purpose media recommended for use in qualitative procedures for the cultivation of aerobes and anaerobes.

The recall was initiated 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. As a result, the expiration date for the affected lots has been shortened from 7 months to 56 days.

The affected lots are 328725, 345633, 346706, 385229, 396646, and 399823. These products were distributed nationwide in the United States and internationally to Singapore. Users should stop using the affected lots and contact Remel Inc for further instructions.

The recalled product

Product
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
Manufacturer
Remel Inc
Category
Medical Device — Laboratory Media
Hazard
Affected units
1,205

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 (6)

  • 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).

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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