Smiths Medical Recalls Portex Unit Dose Normal Saline Due to Sterility Concerns
Smiths Medical is recalling Portex Unit Dose 5 ml Normal Saline 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 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 agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents."
Plain-English summary
Smiths Medical Company is recalling Portex Unit Dose 5 ml Normal Saline (0.9%) due to a lack of sterility assurance. The recall involves 102,000 units of the product, specifically Model # R0059 and Lot Number B360.
The recall was initiated because some containers may be leaking, which could lead to exposure to infectious agents. The affected products were distributed nationwide in the United States, including Puerto Rico, as well as in several international 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 saline units and contact Smiths Medical for further instructions or a replacement.
The recalled product
- Product
- Portex Unit Dose 5 ml Normal Saline (0.9%)¿¿¿¿ ¿
- Affected units
- 102,000
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 # R0059 Lot Number: ¿B360
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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