Z-2286-2021Class I

Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125 The proposed device...

Name: Z-2286-2021 Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125 The proposed device...
Creator: Cardinal Health
Published: 2021-08-04
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2021-08-04 / Open, Classified / root cause: design

FDA source

Cardinal Health began a recall of Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125 The proposed device is indicated for use in flushing compatible... on 2021-08-04. FDA classified it as Class I and gives the reason as "Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2286-2021
Classification: Class I
Status: Open, Classified
Initiated: 2021-08-04
Posted: 2021-08-21
Recalling firm: Medtronic, Inc.
Product: Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
Product code: NGT Saline, Vascular Access Flush
Reason for recall: Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
Root cause tag: design
FDA root cause: Device Design
Action: On August 4, 2021 Cardinal Health issued URGENT MEDICAL DEVICE RECALL notices and response forms to customers via overnight delivery. Customers are advised to take the following actions: 1) REVIEW your inventory for affected product. 2) SEGREGATE and QUARANTINE all on-hand product per the Affected Product table. 3) COMMUNICATE the notice to clinical staff through safety huddles to ensure awareness of this product issue. 4) RETURN the enclosed acknowledgment form via fax to 614-652-9648 or email to [email protected], whether or not you have affected product. 5) CONTACT the appropriate Customer Service group to arrange for return and credit 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 contact the location where they purchased it. For questions related to the notification and/or acknowledgement form that are not adequately addressed in this letter, please contact the market action team at: [email protected] or call 800-292-9332.
Quantity in commerce: 267,217,860 eaches in total
Distribution: US Nationwide Distribution: 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, PI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY.
Product codes and lots: 20D0614 21D0894 20D0624 20D0674 20D0684 20H1504 20H1514

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2286-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2284-2021	Class I	Ongoing	Voluntary: Firm initiated	2021-09-01	2021-08-21
Z-2285-2021	Class I	Ongoing	Voluntary: Firm initiated	2021-09-01	2021-08-21
Z-2286-2021	Class I	Ongoing	Voluntary: Firm initiated	2021-09-01	2021-08-21

Product code NGT

K032438Class IIModification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe, Monojet Prefill Heprin Lock Flush SyringeTyco Healthcare / cleared 2004-06-30

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)