Z-1453-2020Class II

Monoject 3mL Syringe with Hypodermic Safety Needle, 22G x 1-1/2 . Item Code 11832215 -

Name: Z-1453-2020 Monoject 3mL Syringe with Hypodermic Safety Needle, 22G x 1-1/2 . Item Code 11832215 -
Creator: Cardinal Health 200, LLC
Published: 2020-01-15
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2020-01-15 / Terminated / root cause: labeling and UDI

FDA source

Cardinal Health 200, LLC began a recall of Monoject 3mL Syringe with Hypodermic Safety Needle, 22G x 1-1/2 . Item Code 11832215 - Product Usage: used for general purpose injection and aspiration of... on 2020-01-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1453-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-15
Posted: 2020-03-09
Terminated: 2020-12-04
Recalling firm: Medtronic, Inc.
Product: Monoject 3mL Syringe with Hypodermic Safety Needle, 22G x 1-1/2 . Item Code 11832215 - 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.
Product code: KMF Bandage, Liquid
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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 [email protected]) 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.
Quantity in commerce: 8400 each
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.
Product codes and lots: Lot No. 15072015, Item Code 11832215 , Expires 06/20/2020.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1453-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1453-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-18	2020-03-09
Z-1454-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-18	2020-03-09
Z-1455-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-18	2020-03-09
Z-1456-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-18	2020-03-09

Product code KMF

K101359Class IIInvirostripe Luer Lock Syringes (1, 3, 10, 20, 30 and 60 Ml)Inviro Medical Devices, Inc. / cleared 2010-08-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)