The Recall Desk
ModerateFDA (Devices)·Z-1406-2019·Announced 2019-05-29

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

Remel Inc is recalling 1,069 units of Thio Med w/Dex, Hem, Vit K media due to potential performance failures after 106 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 of a diagnostic medium rather than a direct physical injury or high-risk pathogen exposure, fitting the 'Moderate' criteria for low-risk contamination or precautionary measures.

Plain-English summary

Remel Inc is recalling 1,069 units of Thio Med w/Dex, Hem, Vit K (10ml) 20/PK. This product is a general-purpose media recommended for qualitative procedures to cultivate aerobes and anaerobes. The recall is due to the potential for the product to fail performance testing according to the Instructions for Use (IFU) starting at 106 days after the date of manufacturing. Consequently, the expiration date is being shortened from 9 months to 105 days.

The affected lots are identified by Material Number R07182 and specific labeled expiration dates: 309155 (12/12/2018), 329971 (01/17/2019), 346674 (02/26/2019), 354842 (03/07/2019), 376323 (04/18/2019), 398234 (06/06/2019), and 404772 (06/13/2019). The products were distributed nationwide in the United States, including all states, the District of Columbia, and Puerto Rico, as well as internationally to Canada.

Users of this product should check their inventory for the affected lot numbers and expiration dates. If the product is found, it should be discontinued and returned to the supplier or Remel Inc for credit. This recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Thio Med w/Dex, Hem, Vit K (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
1,069

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 (8)

  • Material Number: R07182
  • Lot Number (Labeled Expiration Date): 309155 (12/12/2018)
  • 329971 (01/17/2019)
  • 346674 (02/26/2019)
  • 354842 (03/07/2019)
  • 376323 (04/18/2019)
  • 398234 (06/06/2019)
  • 404772 (06/13/2019).

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 →

Related recalls

Same manufacturer · Remel Inc

See all →

Same hazard · performance failure

See all →