Smiths Medical Recalls Portex Sterile Water Pour Bottles Due to Leaking
Smiths Medical is recalling Portex 500 ml Sterile Water USP Pour Bottles because leaking containers may compromise sterility and expose users 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 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: The recall is classified as FDA Class I, which the rubric defines as a serious health hazard. The source text explicitly states that the defect could lead to exposure to infectious agents, meeting the criteria for a Severe rating.
Plain-English summary
Smiths Medical Company is recalling 9,828 units of Portex 500 ml Sterile Water USP Pour Bottles. The recall was initiated due to a lack of sterility assurance caused by leaking containers, which could lead to exposure to infectious agents.
The affected product is identified by Model # 1565 and Lot Number Y371. The products were distributed nationwide in the United States to numerous states and Puerto Rico, as well as internationally to countries including Austria, Canada, the Czech Republic, Chile, Cyprus, Ecuador, Estonia, Germany, Greece, Italy, Japan, and Switzerland.
Consumers and healthcare facilities should stop using the affected bottles and contact Smiths Medical for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Portex 500 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿
- Category
- Medical Device — Sterile Fluids
- Affected units
- 9,828
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 # 1565 Lot Number: ¿Y371
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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