The Recall Desk
SevereFDA (Devices)·Z-2499-2021·Announced 2021-10-06

DeRoyal Procedure Packs with NORMOFLO Warming Sets Recalled for Aluminum Leaching

DeRoyal procedure packs containing Smiths Medical NORMOFLO warming systems are recalled due to potential aluminum ion leaching into warming fluids. The FDA classified this Class I recall affecting 2880 units distributed in Florida and South Carolina.

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 an FDA Class I recall, which establishes a minimum severity rating of 4 per the rubric. No reported illnesses or injuries are mentioned in the source material. The hazard involves potential aluminum ion leaching into medical fluids.

Plain-English summary

DeRoyal Industries, Inc. is recalling procedure packs containing Smiths Medical NORMOFLO Irrigation Warming Systems due to the potential for aluminum ions to leach into the warming fluids used during procedures. The FDA has classified this recall as Class I.

Aluminum ions leaching from warming system components into medical fluids may pose a health risk during procedures. The recalled procedure packs total 2880 units and were distributed to healthcare facilities in Florida and South Carolina.

Affected units can be identified using specific lot numbers and expiration dates documented in the official FDA recall notice.

The recalled product

Product
DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set
Manufacturer
Deroyal Industries, Inc. Lafollette
Category
Medical Device — Surgical Procedure Pack
Hazard
  • aluminum-leaching

Distribution

Distribution scope not specified by the agency.

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