Medline Prefilled 550 ml Sterile Bags Recalled for Leaking
Medex Cardio-Pulmonary Inc. is recalling 54,924 Medline Prefilled 550 ml Sterile bags due to leaking containers that may compromise sterility.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA has classified this recall as Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death.
Plain-English summary
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company, is recalling 54,924 units of Medline Prefilled 550 ml Sterile bags. The recall involves Model # HCS00550 with lot numbers A092, B205, B534, and Z205.
The recall was initiated because some containers are leaking, which could lead to a lack of sterility assurance and potential exposure to infectious agents. The FDA has classified this as a Class I recall.
The affected products were distributed nationwide in the United States, including Puerto Rico, and in several international countries including Austria, Canada, the Czech Republic, Chile, Cyprus, Ecuador, Estonia, Germany, Greece, Italy, Japan, and Switzerland. Consumers and healthcare facilities should stop using these products and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Medline Prefilled 550 ml Sterile¿¿ ¿
- Category
- Medical Device — Infusion Bags
- Affected units
- 54,924
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 (4)
- Model # HCS00550 Lot Numbers: ¿A092
- B205
- B534
- and Z205
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.
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