FDA Recalls Medline Hudson RCI Addipak Inhalation Solution for Sterility Failure
Medline Industries is recalling HUDSON RCI Addipak 5mL sterile saline inhalation solution due to sterility failure. Approximately 18,000 units were distributed nationwide; the product was intended for scrap but was inadvertently shipped to customers.
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; the rubric requires a minimum severity of 4 (Severe) for Class I recalls. No illnesses or deaths are reported in the source text.
Plain-English summary
Medline Industries, LP is recalling HUDSON RCI Addipak Unit Dose Vials containing 5mL of Sterile 0.9% Sodium Chloride Solution for Inhalation USP. The recalled lot (3B085) consists of approximately 18,000 units distributed nationwide.
The product failed sterility testing and was designated for scrap. However, these units were inadvertently shipped to customers instead of being destroyed as intended.
Consumers and healthcare facilities who received this product should immediately discontinue use and contact their supplier or Medline Industries for replacement. Inhalation products that do not meet sterility requirements should not be used.
The recalled product
- Product
- HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 18,000
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 (2)
- UDI/DI 140267047147818
- Lot code 3B085
Distribution
Distributed nationwide across the United States.
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