FDA Medical Device Recalls (openFDA)
Cardinal Health: 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.
- Recall number
- Z-2286-2021
- Recalling firm
- Cardinal Health
- 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.
- Status
- Open, Classified
- Initiated
- 2021-08-04
- Posted
- not on file
- Terminated
- not on file
- Reason
- Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
- 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 gmbfieldcorrectiveaction@cardinalhealth.com, 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: GMB-FieldCorrectiveAction@cardinalhealth.com or call 800-292-9332.
- Quantity
- 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.
- Lot, serial or model codes
- 20D0614 21D0894 20D0624 20D0674 20D0684 20H1504 20H1514
- 510(k) numbers
- ["K032438"]
- PMA numbers
- not on file
- Product code
- NGT
- Firm FEI
- 3014524790
- Firm city
- Mansfield
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28