Smiths Medical Recalls Sterile Eyewash Due to Leaking Containers
Smiths Medical is recalling 96,828 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 involves a risk of exposure to infectious agents, which aligns with the rubric criteria for Severe severity involving significant injury risks or Class II classifications with potential for serious harm.
Plain-English summary
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company, is recalling 96,828 bottles of Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 32 oz. The product is manufactured by Smiths Medical Company in Vernon Hills, Illinois, and is identified by Model Number 32-005587.
The recall was initiated due to a lack of sterility assurance caused by leaking containers. These leaks could lead to exposure to infectious agents. The affected lots include A257, A258, B017, B116, B119, B120, B131, Z535, and Z638, with expiration dates ranging from October 2017 to May 2019.
The product was distributed in Iowa and Wisconsin. Consumers and healthcare facilities should stop using the affected units and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 32 oz. 12 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: 32-005587
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 (17)
- Lot: A257
- EXP 05-20-2018
- A258
- EXP 05-19-2018
- B017
- EXP 01-12-2019
- B116
- B119
- EXP 05-03-2019
- B120
- EXP 05-04-2019
- B131
- EXP 05-05-2019
- Z535
- EXP 10-13-2017
- Z638
- EXP 12-19-2017.
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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