The Recall Desk
ModerateFDA (Devices)·Z-1407-2019·Announced 2019-05-29

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

Remel Inc is recalling Thio Med w/Dex, Hem, Vit K 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, but the hazard is a performance failure (inaccurate test results) rather than a direct physical injury or contamination, fitting the Moderate category for low-risk quality issues.

Plain-English summary

Remel Inc is recalling 888 units of Thio Med w/Dex, Hem, Vit K(10ml) 100/PK. This product is a general purpose media recommended for use in qualitative procedures for the cultivation of aerobes and anaerobes. The recall is due to a potential for the products 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 is being shortened from 9 months to 105 days.

The affected lots are identified by Material Number R07180 and specific Lot Numbers corresponding to expiration dates ranging from 12/20/2018 to 07/18/2019. The specific lot numbers are 314206, 315673, 322659, 330648, 333828, 337102, 343936, 347392, 353577, 366056, 367423, 370220, 377044, 380480, 390571, 391563, 407306, and 418374.

The products were distributed nationwide in the United States to all states, the District of Columbia, and Puerto Rico, as well as internationally to Canada. Users should check their inventory for these specific lot numbers and stop using the product if it is past the revised 105-day expiration window.

The recalled product

Product
Thio Med w/Dex, Hem, Vit K(10ml) 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
888

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 (19)

  • Material Number: R07180
  • Lot Number (Labeled Expiration Date): 314206 (12/20/2018)
  • 315673 (12/25/2018)
  • 322659 (01/07/2019)
  • 330648 (01/21/2019)
  • 333828 (01/24/2019)
  • 337102 (01/31/2019)
  • 343936 (02/14/2019)
  • 347392 (02/28/2019)
  • 353577 (03/06/2019)
  • 366056 (03/28/2019)
  • 367423 (04/02/2019)
  • 370220 (04/09/2019)
  • 377044 (04/22/2019)
  • 380480 (04/29/2019)
  • 390571 (05/16/2019)
  • 391563 (05/20/2019)
  • 407306 (06/20/2019)
  • 418374 (07/18/2019).

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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