Smiths Medical Recalls Sterile Eyewash Due to Leaking Containers
Smiths Medical is recalling 22,080 bottles of Sterile Eyewash because leaking containers may compromise sterility and expose users to infectious agents.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 as an FDA Class II recall. The hazard involves a lack of sterility assurance in a sterile medical product, which poses a significant risk of exposure to infectious agents, meeting the criteria for a Severe rating.
Plain-English summary
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company, is recalling 22,080 bottles of Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 4 oz. The product is manufactured by Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company, located in Vernon Hills, Illinois, and is identified by Model Number 32-005583 and Lot A225.
The recall was initiated due to a lack of sterility assurance. The source text indicates that leaking containers could lead to exposure to infectious agents. The affected units were distributed in Iowa and Wisconsin.
Consumers and healthcare facilities should stop using the affected product and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 4 oz. 24 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois, USA 60061. Model Number: 32-005583
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)
- Lot: A225
Distribution
Part of a larger recall action
This product is one of 4 recalled by Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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