—#179555

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 injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin.

FDA product code: GEA — Cannula, Surgical, General & Plastic Surgery
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot No. 15072024, Item Code 11811022F, Expires 06/20/2020

Why it was 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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Cardinal Health URGENT MEDICAL DEVICE RECALL EVENT #: 2019-02623 letter dated January 15, 2020. Customers were advised that this recall is being conducted of product labeled as NON-STERILR Not For Human Use (Exhibit A). Action required includes the following: 1.CHECK all storage and usage locations to confirm whether you have any units of the affected product codes and lot numbers containing the labeling outlined in Exhibit A in your possession. Exhibit A outlines examples of product labeling and how to identify the affected product. 2.SEGREGATE and QUARANTINE all on-hand product that is confirmed to be labeled per Exhibit A. 3.PLEASE RETURN the enclosed acknowledgment form via facsimile (847-689-9101 or 614-652-9648) or email (GMB FieldCorrectiveAction@cardinalhealth.com) and indicate the product code, lot and quantity of product youve quarantined or discarded. Please respond regardless of whether or not you have affected product. 4.NOTIFY any customers to whom you may have distributed, or forwarded product affected by this recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. 5.CONTACT the appropriate Customer Service group to arrange for return and credit/replacement of any affected product Monday Friday between 8:00am - 5:00pm EST: " Hospital800-964-5227 " Federal Government800-444-1166 " Distributor800-635-6021 " All other Customers888-444-5440 6.Customers that did not receive product directly from Cardinal Health should return product through the location where they purchased it.

Recalling firm

Firm: Cardinal Health
Address: 200 LLC 15 Hampshire St, Bldg 5, Mansfield, Massachusetts 02048-1113

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2020-01-15
Terminated: 2020-12-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #179555. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.