Medline Sterile Water and Saline bottles recalled for leaking containers
Medline Sterile Water and 0.9% Normal Saline bottles are recalled due to leaking at the bottle opening interface, which may compromise product sterility and safety for medical use.
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 a medical device with a real container integrity defect affecting sterile injectable solutions. While no illnesses or injuries are reported in the source material, the leaking compromises product sterility, creating significant risk of infection. This meets the rubric criterion for score 3: risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medline Industries is recalling its Sterile Water, USP, 100mL (REF RDI30295) and Sterile 0.9% Normal Saline bottles. The bottles leak at the interface where the peel-foil seal meets the bottle opening. A total of 963,054 units are affected.
These sterile solutions are used for medical and pharmaceutical applications. A leaking container may allow external contaminants to compromise the solution's sterility, making it unsafe for medical use.
The recalled products were distributed nationwide throughout the United States as well as to Panama and Canada.
Healthcare providers and consumers should discontinue use of affected bottles and contact Medline Industries or their supplier for replacement or return instructions.
The recalled product
- Product
- Medline Sterile Water, USP, 100mL, REF RDI30295
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- container-leak
- contamination-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 (17)
- UDI/DI 10884389338230 (EA) 40884389338231 (CS)
- Lot Numbers: 23CJA159
- 23GJA086
- 23HJA080
- 23JJA010
- 23KJA047
- 23LJA031
- 23LJA089
- 24AJA095
- 24AJA157
- 24CJA089
- 24IJA004
- 24IJA036
- 24JJA164
- 24KJA008
- 24KJA051
- 24KJA108.
Distribution
Distributed nationwide across the United States.
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