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U.S. Department of Health and Human Services

Class 1 Device Recall Monoject 0.9 Sodium Chloride Flush Syringe

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  Class 1 Device Recall Monoject 0.9 Sodium Chloride Flush Syringe see related information
Date Initiated by Firm August 04, 2021
Create Date August 21, 2021
Recall Status1 Open3, Classified
Recall Number Z-2286-2021
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, 5mL Fill, STERILE, Product Code 8881570125

The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
Code Information 20D0614 21D0894 20D0624 20D0674 20D0684 20H1504 20H1514 
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 2		 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
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