The Recall Desk
HighFDA (Devices)·Z-0038-2025·Announced 2024-10-16

3M Tegaderm CHG I.V. Dressing Recalled for Foreign Contamination

3M is recalling Tegaderm CHG I.V. Securement Dressing (REF 1658R) due to contamination with foreign substance matter. The affected lot (33WWRRR) was distributed to South Korea.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device with foreign contamination, classified as a risk-of-harm product. No illnesses or injuries have been reported, which prevents a Severe rating, but the inherent risk of contamination in an invasive medical device (I.V. securement dressing) warrants a High severity rating.

Plain-English summary

3M Company is recalling 3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing (REF 1658R) due to contamination with foreign substance matter.

The affected product is lot number 33WWRRR (UDI 10707387802223 for carton, 30707387802227 for individual units). The dressing is intended to secure intravenous (I.V.) lines at the insertion site.

The recalled lot was distributed internationally to South Korea. A total of 10,000 units have been identified as affected.

Healthcare providers and hospitals that received the affected lot should discontinue use immediately and contact 3M Company for guidance on return or replacement product.

The recalled product

Product
3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Manufacturer
3M Company - Health Care Business
Category
Medical Device — I.V. Securement Dressing
Hazard
  • foreign-contamination

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 (3)

  • UDI/DI 10707387802223 (carton)
  • UDI/DI 30707387802227 (each)
  • Lot Number 33WWRRR

Distribution

Distribution scope not specified by the agency.

Related recalls

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