The Recall Desk
SevereFDA (Devices)·Z-1093-2024·Announced 2024-03-06

Medline Bronchoscopy Tray Components Recalled for Potential Lack of Sterility

Medline Industries is recalling certain Nurse Assist components used in Bronchoscopy Trays due to potential lack of sterility. Affected irrigation solutions and saline flush syringes may be non-sterile.

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: FDA classified this as a Class I recall for medical devices. Per the severity rubric, FDA Class I recalls must receive a minimum severity score of 4. Although no illnesses or injuries are reported in the source, potential non-sterility in medical irrigation solutions used in clinical procedures represents a serious infection risk.

Plain-English summary

Medline Industries, LP is recalling specific lots of components used in certain Bronchoscopy Trays manufactured with Nurse Assist products. The recalled items include 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe. The affected lot numbers are 2022022550, 2022050550, and 2022051050.

The recall was issued due to the potential lack of sterility in these components. The solutions may be non-sterile, which could result in infections during medical procedures.

The affected products have been distributed nationwide throughout the United States, including Puerto Rico, and internationally to Canada, the United Arab Emirates, and Panama.

The recalled product

Product
MEDLINE BRONCHOSCOPY TRAY, REF DYNDL1350A
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • sterility-compromise
  • infection-risk

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 (5)

  • UDI/DI 40889942880486 (case)
  • 10889942880485 (unit)
  • Lot Numbers: 2022022550
  • 2022050550
  • 2022051050

Distribution

Distributed nationwide across the United States.