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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Hazard
- Affected units
- 2,880
Distribution
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