Reported Nov 28, 2018 · Terminated
Irrisept OR, Finished Bottle Assembly 450 ml STEP 1
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company · 330 Corporate Woods Pkwy · Vernon Hills, IL · 60061-3107
Is this the product you have?
- Irrisept OR, Finished Bottle Assembly 450 ml STEP 1
- Lot codes and dates
- Model #
- FB-A-400-107 Lot Number4J006
- Amount recalled
- 10,440
Where it was sold
Why it was recalled
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
This product could cause temporary or reversible health problems — stop using it.
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