Recall Z-2284-2021
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, 10 mL Fill, STERILE, Product Code 8881570121 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
Codes / lots: 19G0814 19G0824 19G0834 19G0844 19G0854 19G0864 19G0874 19G0894 19H0914 19H0924 19H0934 19H0944 19H0954 19H0964 19H0974 19H0984 19H0994 19H1014 19H1004 19H1024 19I1034 19I1054 19I1074 19I1084 19I1104 19I1114 19I1134 19I1144 19I1154 19J1184 19J1194 19J1204 19J1234 19J1244 19J1254 19J1284 19J1294 19J1304 19K1354 19L1364 19L1374 19L1384 20A0014 20A0024 20A0064 20A0034 20A0044 20A0054 20A0074 20A0084 20A0094 20A0104 20A0114 20A0124 20A0154 20A0144 20A0164 20A0184 20A0194 20B0204 20B0214 20B0224 20B0244 20B0234 20B0254 20B0264 20B0294 20B0274 20B0284 20B0304 20B0344 20B0314 20B0324 20B0394 20C0374 20B0334 20B0354 20B0364 20C0384 20C0414 20C0424 20C0454 20C0434 20C0444 20C0474 20C0464 20C0404 20C0484 20C0494 20C0504 20C0514 20C0524 20C0534 20C0544 20C0554 20C0564 20C0574 20C0584 20D0594 20D0604 20D0634 20D0644 20D0654 20D0664 20D0704 20D0714 20D0724 21D1014 20D0734 20D0744 20D0754 20D0764 20D0774 20E0824 20E0834 20E0844 20E0854 20E0864 20E0874 20E0914 20E0884 20E0894 20E0904 20E0924 20E0934 20E0974 20E0984 20E0994 20F1004 20F1014 20F1024 20F1034 20F1044 20F1074 20F1084 20F1094 20F1104 20F1124 20F1174 20F1134 20F1144 20F1184 20F1154 20F1164 20F1194 20F1214 20F1224 20G1284 20G1234…
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-2284-2021
- 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-2285-2021 Class I | Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code 8881570123…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 |