Smiths Medical Recalls Sterile Eyewash Due to Leaking Containers
Smiths Medical is recalling 29,232 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 recall is classified as FDA Class II, and the hazard involves exposure to infectious agents due to a loss of sterility, which meets the criteria for a Severe rating.
Plain-English summary
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company, is recalling 29,232 bottles of 1-ounce Sterile Eyewash (sterile isotonic phosphate buffered saline solution). The product is identified by Lot Z516 and Model Number 32-005582. 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 affected units were distributed in Iowa and Wisconsin. The product is manufactured by Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company, located in Vernon Hills, Illinois.
Consumers and healthcare facilities should stop using the affected product and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 1 oz. 144 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: 32-005582.
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: Z516
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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