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.
What this means for you
Illness, injury, or structural failure has been reported. 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¿¿¿¿ ¿¿¿¿ ¿
- 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
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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