Smiths Medical Recalls Portex Normal Saline Units Due to Sterility Concerns
Smiths Medical is recalling Portex Unit Dose 15 ml Normal Saline products because leaking containers may compromise sterility, potentially exposing patients to infectious agents.
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: The recall involves a risk of exposure to infectious agents due to compromised sterility, which fits the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company, is recalling Portex Unit Dose 15 ml Normal Saline products. The recall is due to a lack of sterility assurance, as leaking containers could lead to exposure to infectious agents.
The affected products include Model # R0159 with lot numbers A661, B067, A526, A536, A569, and B201. A total of 357,552 units were distributed worldwide, including nationwide in the United States and in several international countries such as Canada, Germany, and Japan.
Consumers and healthcare providers should stop using the affected products and contact Smiths Medical for further instructions or a replacement.
The recalled product
- Product
- Portex Unit Dose 15 ml Normal Saline ¿
- Affected units
- 357,552
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 (6)
- Model # R0159 Lot Numbers: ¿A661
- B067
- A526
- A536
- A569
- and B201
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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