Irrisept OR recall: Sterility Concern
Irrisept OR, Finished Bottle Assembly 450 ml STEP 1
Why was Irrisept OR recalled?
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model # FB-A-400-107 Lot Number: 4J006
- Product
- Irrisept OR, Finished Bottle Assembly 450 ml STEP 1
- Recalling firm
- Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
- Quantity
- 10,440
- Distribution
- AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, and WI
- Recall date
- November 28, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)