Smiths Medical Recalls Portex Sterile Water Pour Bottles Due to Leaking
Smiths Medical is recalling Portex 1000 ml Sterile Water USP Pour Bottles because leaking containers may lack sterility assurance, posing a risk of exposure to infectious agents.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source metadata explicitly identifies the agency classification as Class I. Per the rubric, FDA Class I recalls are assigned a severity score of 5 (Critical) regardless of other factors.
Plain-English summary
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company, is recalling 21,876 units of Portex 1000 ml Sterile Water USP Pour Bottles. The recall involves Model # 1065 with Lot Numbers B209 and Z225. The product was distributed nationwide in the United States, including Puerto Rico, and internationally to countries including Austria, Canada, the Czech Republic, Chile, Cyprus, Ecuador, Estonia, Germany, Greece, Italy, Japan, and Switzerland.
The recall is due to a lack of sterility assurance caused by leaking containers. This defect could lead to exposure to infectious agents. The source text does not report any specific illnesses or injuries associated with this recall.
Healthcare facilities and consumers should stop using the affected bottles and contact the recalling firm for instructions on return or disposal. The FDA has classified this as a Class I recall, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
The recalled product
- Product
- Portex 1000 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿
- Category
- Medical Device — Sterile Water
- Affected units
- 21,876
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 (1)
- Model # 1065 Lot Numbers: B209 and Z225
Distribution
Part of a larger recall action
This product is one of 13 recalled by Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company 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.
See all 13 products in this recall →Related recalls
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