Monoject Bluntfill with Filter recall: Sterility Concern
Monoject Bluntfill with Filter, 18G x 1-1/2" Item Code 11811022F. Used for drawing fluid from a vial - Product Usage: used for general purpose…
Why was Monoject Bluntfill with Filter recalled?
Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile. The usage of a needle that is not sterile could result in infection. Firm is not aware of any reports of patient harm.
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?
Lot No. 15072024, Item Code 11811022F, Expires 06/20/2020
- Product
- Monoject Bluntfill with Filter, 18G x 1-1/2" Item Code 11811022F. Used for drawing fluid from a vial - Product Usage: used for general purpose…
- Recalling firm
- Cardinal Health 200, LLC
- Quantity
- 8000
- Distribution
- Worldwide distributions - US Nationwide distributions in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and countries of Canada, Australia, South Africa, Belgium, Germany, Ireland, Portugal Spain, and UK.
- Recall date
- March 18, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)