Agency classClass IOur severity:Severe FDA (Devices)·Z-0721-2019·Announced 2019-02-13

Smiths Medical Recalls Portex 5ml Normal Saline Units Due to Sterility Issues

Smiths Medical is recalling 106,000 units of Portex 5ml Normal Saline due to leaking containers that may compromise sterility and expose 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 106,000 units of Portex 5ml Normal Saline (0.9%) Unit Dose. The recall is due to a lack of sterility assurance caused by leaking containers, which could lead to exposure to infectious agents.

The affected product is Model # UD9005, Lot Number B515. Distribution was worldwide, including nationwide distribution in the United States to numerous states and Puerto Rico, as well as to Austria, Canada, the Czech Republic, Chile, Cyprus, Ecuador, Estonia, Germany, Greece, Italy, Japan, and Switzerland.

Healthcare providers and consumers should stop using the affected product and contact Smiths Medical for instructions on return or replacement.

The recalled product

Product: Portex 5ml Normal Saline (0.9%) Unit Dose¿¿¿¿ ¿
Manufacturer: Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Category: Medical Device — Infusion Supplies
Hazard: infection
sterility-failure
Affected units: 106,000

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 # UD9005 Lot Number: ¿B515

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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Critical
Smiths Medical Recalls Portex Sterile Water Humidifiers Due to Leaking
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Smiths Medical Recalls Intermed 350 ml Sterile Water Humidifiers
FDA (Devices) · 2019-02-13
Severe
Medline Prefilled 350 ml Sterile Solution Recall Due to Leaking
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Same hazard · infection