The Recall Desk
SevereFDA (Devices)·Z-2377-2021·Announced 2021-09-15

NORMOFLO Irrigation Warming Sets Recalled for Aluminum Leaching Risk

Smiths Medical is recalling NORMOFLO Irrigation Warming sets (Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700) due to potential aluminum leaching when used at lower flow rates with certain solutions and blood products. No illnesses have been reported.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I designation mandates a minimum severity score of 4. Although the hazard involves potential aluminum leaching rather than confirmed patient harm and no illnesses have been reported, the classification reflects the serious risk posed by trace metal contamination in medical irrigation sets.

Plain-English summary

Smiths Medical ASD Inc. is recalling NORMOFLO Irrigation Warming administration sets (disposable) in Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, and IR-700. Approximately 519,250 units have been distributed.

The recall was initiated because these sets have the potential to leach harmful levels of aluminum when used at lower flow rates with certain solutions and blood products during extended periods of use. This risk is specific to certain conditions of use rather than affecting all applications.

The affected sets have been distributed nationwide throughout the United States and internationally to Austria, Australia, Belgium, Switzerland, Canada, Germany, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Hungary, Ireland, Italy, Kuwait, Luxembourg, Netherlands, New Zealand, Panama, Poland, Portugal, Sweden, Turkey, Venezuela, and South Africa.

As of the recall announcement, no illnesses or injuries related to this issue have been reported. Healthcare facilities and medical providers with affected inventory should contact Smiths Medical ASD Inc. or the FDA for guidance on appropriate actions. The recall has been designated as FDA Class I and assigned recall identifier Z-2377-2021.

The recalled product

Product
NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700
Manufacturer
Smiths Medical ASD Inc.
Category
Medical Device — IV Administration Set
Hazard
  • aluminum-leaching

Distribution

Distributed nationwide across the United States.

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