Recall Z-1455-2020
Cardinal Health 200, LLC · initiated January 15, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Monoject Hypodermic Safety Needle 25G x 5/8" Item Code 1182558 - 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.
Codes / lots: Lot No. 15063004, Item Code 1182558, Expires 5/31/2020
Reason for recall
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.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-1455-2020
- Initiated
- January 15, 2020
- Terminated
- December 4, 2020
- Product code
- FMI – Needle, Hypodermic, Single Lumen
- 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.
- Recalling firm
- Cardinal Health 200, LLC, Mansfield, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1453-2020 Class II | Monoject 3mL Syringe with Hypodermic Safety Needle, 22G x 1-1/2 . Item Code 11832215 -…Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR"… | 01/15/2020Terminated |
| Z-1454-2020 Class II | Monoject Hypodermic Safety Needle 30G X 1/2" Item Code 1183005 - Product Usage: used for…Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR"… | 01/15/2020Terminated |
| Z-1456-2020 Class II | Monoject Bluntfill with Filter, 18G x 1-1/2" Item Code 11811022F. Used for drawing fluid…Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR"… | 01/15/2020Terminated |