Agency classClass IOur severity:Severe FDA (Devices)·Z-0720-2019·Announced 2019-02-13

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.

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

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 ¿
Manufacturer: Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Category: Medical Device — Infusion Supplies
Hazard: infection
sterility-failure
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

Distributed nationwide across the United States.

The notice also names 37 states specifically:

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 →

Same manufacturer · Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

See all →

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Same hazard · infection