Recall Z-2285-2021
Cardinal Health · initiated August 4, 2021
Class I – dangerous or defective products that could cause serious health problems or death
Product
Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code 8881570123 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
Codes / lots: 20I1524 20D0694 20I1584
Reason for recall
Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-2285-2021
- Initiated
- August 4, 2021
- Product code
- NGT – Saline, Vascular Access Flush
- 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.
- Recalling firm
- Cardinal Health, Mansfield, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2284-2021 Class I | Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code…Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the… | 08/04/2021Open, Classified |
| Z-2286-2021 Class I | Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125…Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the… | 08/04/2021Open, Classified |