The Recall Desk
SevereFDA (Devices)·Z-2514-2023·Announced 2023-09-20

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.

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; 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
Category
Medical Device — Sterile Inhalation Solution
Hazard
  • sterility-failure
  • contamination

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.

Related recalls

Same category