Agency classClass IOur severity:Severe FDA (Devices)·Z-0718-2019·Announced 2019-02-13

Medline Prefilled 350 ml Sterile Solution Recall Due to Leaking

Medex Cardio-Pulmonary Inc. is recalling 235,560 units of Medline Prefilled 350 ml Sterile Solution because leaking containers 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 recall is classified as FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. The hazard involves exposure to infectious agents due to compromised sterility.

Plain-English summary

Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company, is recalling 235,560 units of Medline Prefilled 350 ml Sterile Solution. 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 # HCS00350. Specific lot numbers involved include A055, A056, A057, A058, A103, A176, A455, B530, B531, B532, B533, Z101, Z534, Z553, and Z554. The product was distributed nationwide in the United States and in several international countries, including Austria, Canada, the Czech Republic, Chile, Cyprus, Ecuador, Estonia, Germany, Greece, Italy, Japan, and Switzerland.

Healthcare providers and consumers should check their inventory for the specific model and lot numbers listed above. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations to prevent potential exposure to infectious agents.

The recalled product

Product: Medline Prefilled 350 ml Sterile¿¿¿¿ ¿¿¿¿ ¿
Manufacturer: Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Category: Medical Device — Infusion Solution
Hazard: infection
sterility-compromise
Affected units: 235,560

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 (15)

Model # HCS00350 Lot Numbers: ¿A055
A056
A057
A058
A103
A176
A455
B530
B531
B532
B533
Z101
Z534
Z553
and Z554

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

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Same hazard · infection