Class 1 Device Recall Monoject 0.9 Sodium Chloride Flush Syringe

• Date Initiated by Firm: August 04, 2021
• Create Date: August 21, 2021
• Recall Status: Open, Classified
• Recall Number: Z-2284-2021
• Recall Event ID: 88421
• 510(K)Number: K032438
• Product Classification: Saline, vascular access flush - Product Code NGT
• 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.
• Code Information: 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 20G1244 20G1254 20G1294 20G1264 20G1314 20G1334 20G1344 20H1304 20H1354 20H1364 20H1374 20H1384 20H1394 20H1414 20H1424 20H1404 20H1434 20H1444 20H1494 20H1454 20H1464 20H1474 20H1484 20H1534 20H1544 20I1554 20I1564 20I1574 20I1624 20I1634 20I1644 20I1654 20I1664 20I1674 20I1684 20I1694 20I1704 20I1714 20I1764 20I1774 20J1784 20J1794 20J1804 20J1824 20J1834 20J1844 20J1854 20J1864 20J1914 20J1924 20J1934 20J1944 20J1954 20J2074 19J1324 20J2084 19J1334 20J2094 20K2144 20K2104 20K2114 19K1344 20K2164 20K2154 20K2174 20K2184 20K2194 20K2204 20K2224 20K2264 20K2274 20K2234 20K2284 20K2294 20K2304 20K2404 20K2344 20K2414 20K2424 20L2394 20L2434 20L2484 20L2494 20L2504 20L2474 20L2514 20L2524 20L2564 20L2604 20L2614 20L2574 20L2624 20L2634 20L2644 21A0014 21A0024 21A0034 21A0044 21A0054 21A0114 21A0124 21A0134 21A0144 21A0184 21A0194 21A0204 21A0214 21A0294 21B0304 21B0314 21B0324 21B0374 21B0384 21B0394 21B0404 21B0444 21B0454 21B0464 21B0474 21B0514 21B0524 21B0534 21C0544 21C0584 21C0594 21C0604 21C0614 21C0654 21C0664 21C0674 21C0684 21C0724 21C0734 21C0744 21C0754 21C0794 21C0804 21D0814 21D0824 21D0904 21D0914 21D0924 21D0934 21D1024 21D1034 21D1044 21E1114 21E1124 21E1134 21E1144 21E1244 21E1254 21E1264 21F1274 21F1414 21F1424 21F1434 21F1444 21F1524 21F1534 21F1544
• Recalling Firm/ Manufacturer: Cardinal Health; 777 West St; Mansfield MA 02048-1122
• Manufacturer 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: 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 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = NGT and Original Applicant = TYCO HEALTHCARE