The Recall Desk
SevereFDA (Devices)·Z-2376-2021·Announced 2021-09-15

NORMOFLO Irrigation Fluid Warmer Recalled for Risk of Aluminum Leaching

Smiths Medical recalls NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129 (913 units) due to potential harmful aluminum leaching when used at lower flow rates with certain solutions and blood products.

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: This is classified as FDA Class I, which indicates reasonable probability of causing serious adverse health consequences. Although no illnesses or injuries have been reported in the source, the Class I designation reflects the potential seriousness of aluminum leaching in medical applications involving blood products.

Plain-English summary

The NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129, manufactured by Smiths Medical ASD Inc., are being recalled. These devices were distributed nationwide in the United States and internationally.

The recall is due to potential for harmful levels of aluminum leaching when the device is used at lower flow rates with certain solutions and blood products during extended use. This leaching could result in elevated aluminum exposure to patients.

Affected healthcare facilities should verify their inventory against the product codes (CON-H1100, H-1100 variants for Model H-1100; H-1129 for Model H-1129) and discontinue use of recalled units. Contact Smiths Medical ASD Inc. for instructions on remediation or replacement.

The recalled product

Product
NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129
Manufacturer
Smiths Medical ASD Inc.
Category
Medical Device — Surgical Equipment
Hazard
Affected units
913

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 (9)

  • Model H-1100: Product Codes CON-H1100
  • H-1100
  • H-1100-ES-115V
  • H-1100-ES-230V
  • H-1100-FR-230V
  • H-1100-INT-230
  • H-1100-IT-230V
  • H-1100-NL-230V H-1100-SV-230V
  • H-1100-UK-230 Model H-1129: Product Code H-1129

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Smiths Medical ASD 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 2 products in this recall →

Related recalls

Same manufacturer · Smiths Medical ASD Inc.

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Same hazard · aluminum leaching

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