The Recall Desk
HighFDA (Devices)·Z-1121-2024·Announced 2024-03-06

Medline Nursing Education Kits Recalled for Potential Lack of Sterility

Medline Industries recalls 844 units of nursing education kits and trays due to potential lack of sterility in Nurse Assist irrigation solution components. Products distributed nationwide and internationally.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class I recall involving potential lack of sterility in medical irrigation solutions. While the hazard is serious and could result in infection, no illnesses or injuries have been reported in the source material, making the risk theoretical rather than actualized.

Plain-English summary

Medline Industries, LP is recalling 844 units of nursing education kits and trays containing Nurse Assist components. The affected products are labeled NUR 105 (REF EDUC05053B), NUR 213 (REF EDUC05054B), NURSING SKILLS (REF EDUC05050B), and NURSING SUPPLY BAG (REF EDUC1024). These kits contain 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringes.

The recall was issued because the Nurse Assist components may lack sterility. Non-sterile irrigation solutions could present a risk when used in clinical or educational settings.

The affected kits were distributed throughout the United States, Puerto Rico, Canada, the United Arab Emirates, and Panama. Specific lot numbers and UDI codes are identified in the FDA recall notice.

Users of these products should discontinue use immediately and contact Medline Industries for instructions regarding returns or replacement.

The recalled product

Product
Medline Kits, trays, and packs labeled as follows: a) NUR 105, REF EDUC05053B; b) NUR 213, REF EDUC05054B; c) NURSING SKILLS, REF EDUC05050B; d) NURSING SUPPLY BAG, REF EDUC1024
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • lack-of-sterility

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 (20)

  • a) REF EDUC05053B
  • UDI/DI 40195327152759 (case)
  • 10195327152758 (unit)
  • Lot Numbers: 22HDA208
  • b) REF EDUC05054B
  • UDI/DI 40195327152766 (case)
  • 10195327152765 (unit)
  • Lot Numbers: 22FDA648
  • 22GDA631
  • c) REF EDUC05050B
  • UDI/DI 40195327166749 (case)
  • 10195327166748 (unit)
  • Lot Numbers: 22HLA620
  • 22HLB059
  • 22ILA209
  • 22ILA210
  • 22KLA131
  • 22LLA961
  • 23GLA207
  • 23GLA933

Distribution

Distributed nationwide across the United States.