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Class 1 Device Recall Monoject 0.9 Sodium Chloride Flush Syringe |
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Date Initiated by Firm |
August 04, 2021 |
Create Date |
August 21, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-2285-2021 |
Recall Event ID |
88421 |
510(K)Number |
K032438
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Product Classification |
Saline, vascular access flush - Product Code NGT
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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. |
Code Information |
20I1524 20D0694 20I1584 |
Recalling Firm/ Manufacturer |
Cardinal Health 777 West St Mansfield MA 02048-1122
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Manufacturer Reason for Recall |
Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
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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
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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.
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510(K) Database |
510(K)s with Product Code = NGT and Original Applicant = TYCO HEALTHCARE
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