MEDLINE Serum Tear Kit Irrigation Solutions Recalled for Sterility Concerns
Medline is recalling serum tear kit irrigation solutions due to potential sterility defects. The solutions may not be sterile, posing contamination risks during medical use.
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: FDA Class I classification for medical device recalls requires a minimum severity rating of Severe. While no illnesses or injuries have been reported, the potential for sterility defects in irrigation solutions used in medical procedures presents a significant risk of harm.
Plain-English summary
Medline Industries, LP is recalling MEDLINE Serum Tear Kits (Reference number DYNDA1545) that contain irrigation solutions manufactured with specific lot numbers that may not be sterile.
The recalled products include 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe from specific lots (22FMC728, 23CMB090). Nurse Assist, the component manufacturer, initiated the recall due to potential lack of sterility in these solutions, which could result in non-sterile product reaching patients.
The affected kits were distributed nationwide in the United States as well as Puerto Rico, Canada, United Arab Emirates, and Panama. Medical professionals and facilities that received these kits should immediately stop using products from the identified lots.
Consumers and healthcare providers should contact Medline Industries or review the FDA recall information for proper handling and return procedures.
The recalled product
- Product
- MEDLINE Kits, trays, and packs labeled as follows: SERUM TEAR KIT, REF DYNDA1545
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
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 (4)
- UDI/DI 40889942214885 (case)
- 10889942214884 (unit)
- Lot Numbers: 22FMC728
- 23CMB090
Distribution
Part of a larger recall action
This product is one of 49 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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