The Recall Desk
ModerateFDA (Devices)·Z-1404-2019·Announced 2019-05-29

Remel Thio Med Media Recalled for Potential Performance Failure

Remel Inc is recalling Thio Med w/o Ind, w/Dex media because it may fail performance testing after 106 days. The expiration date is being shortened to 105 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. The hazard is a potential failure to meet performance specifications rather than a direct physical injury or contamination risk, and no illnesses or injuries are reported.

Plain-English summary

Remel Inc is recalling 282 units of Thio Med w/o Ind, w/Dex (10ml) 20/PK. This 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 106 days after the date of manufacturing. As a result, the expiration date for the affected lots is being shortened from 9 months to 105 days.

The affected products were distributed nationwide in the United States and internationally to Canada. Specific lot numbers and expiration dates are listed in the recall documentation. Users should check their inventory for the specific material and lot numbers identified in the recall notice and stop using any affected units.

The recalled product

Product
Thio Med w/o Ind, w/Dex (10ml) 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
282

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 (10)

  • Material Number: R08852
  • Lot Number (Labeled Expiration Date): 307916 (12/11/2018)
  • 337081 (01/31/2019)
  • 359857 (03/19/2019)
  • Lot Number (Labeled Expiration Date): 311677 (12/18/2018)
  • 347391 (02/28/2019)
  • 366062 (03/28/2019)
  • 390570 (05/16/2019)
  • 396653 (05/30/2019)
  • 417781 (07/17/2019).

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

Part of a larger recall action

This product is one of 10 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 10 products in this recall →

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