Medline Sterile Water and Saline Bottles Recalled Due to Leaking
Medline Sterile Water and 0.9% Normal Saline bottles may leak at the peel-foil seal, potentially compromising sterility. Units were distributed to the US, Panama, and Canada.
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: FDA Class II recall of sterile water and saline bottles with potential contamination risk from leaking seals. No illnesses, injuries, or deaths have been reported. Per the rubric, when no actual harm is reported and the hazard is theoretical, the maximum score is 3. The product poses high-risk due to its use in medical procedures.
Plain-English summary
Medline Industries is recalling Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles (lot 23JBU525) because the bottles may leak at the interface where the peel-foil seal meets the bottle opening.
If the seal is compromised, the bottles are no longer sterile and cannot be safely used for medical procedures such as wound irrigation or injections. Leaking bottles may have been exposed to contamination.
The recalled bottles were distributed worldwide, including throughout the United States, Panama, and Canada. Approximately 120 units were affected.
If you have received these bottles, do not use them. Contact your supplier or Medline Industries for instructions on how to obtain replacement products.
The recalled product
- Product
- Medline procedure kits, labeled as: PLASTICS SUTURE TRAY, REF SUT13535
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- leaking-container
- sterility-compromise
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 10653160144250 (EA) 40653160144251 (CS)
- Lot Numbers: 23JBU525
Distribution
Distributed nationwide across the United States.
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