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U.S. Department of Health and Human Services

Class 2 Device Recall Monoject Standard Hypodermic Needle

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 Class 2 Device Recall Monoject Standard Hypodermic Needlesee related information
Date Initiated by FirmSeptember 25, 2020
Create DateNovember 05, 2020
Recall Status1 Terminated 3 on October 30, 2023
Recall NumberZ-0424-2021
Recall Event ID 86554
510(K)NumberK854547 
Product Classification Needle, hypodermic, single lumen - Product Code FMI
ProductCovidien MONOJECT Standard Hypodermic Needle, Polypropylene Hub 22 G x 3/4". Intended use to facilitate activities such as: withdrawal of medication from a container, aspiration of fluid from a patient, injection of medication into a patient, and transfer fluids Item Code: 8881250248
Code Information Lot Number: 011144  Expanded Recall 11/4/20: Lot Number: 011145
FEI Number 3014524790
Recalling Firm/
Manufacturer		 Cardinal Health 200, LLC
15 Hampshire St Bldg 5
Mansfield MA 02048-1113
Manufacturer Reason
for Recall		Potential for the needle to detach from the cartridge after the bottom of the cartridge is twisted and removed. If the needle is not securely seated, the needle can fall out of the sheath and cause the unused needle to project out of the cartridge, and result in a needle stick/puncture from the clean/unused needle
FDA Determined
Cause 2		Under Investigation by firm
ActionCardinal Health issued Urgent Medical Device Recall on 9/25/20 overnight mail. Letter states reason for recall, health risk, and action to take: 1.INSPECT your inventory for the affected product code and lot number (see Attachment A). 2. SEGREGATE and QUARANTINE all on-hand product. 3. PLEASE RETURN the enclosed acknowledgment form via facsimile (847-689-9101 or 614-652- 9648) or email (GMB-FieldCorrectiveAction@cardinalhealth.com) and indicate the product code, lot and quantity of product youve quarantined or discarded. Please respond regardless of whether or not you have affected product. 4. NOTIFY any customers to whom you may have distributed, or forwarded product affected by thisrecall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. 5. CONTACT the appropriate Customer Service group to arrange for return and credit/replacement of any affected product Monday  Friday between 8:00am - 5:00pm EST: Hospital800-964-5227; Federal Government800-444-1166 Distributor800-635-6021; All other customers888-444-54401 Cardinal intends to send a letter on 11/4/2020, to customers with an additional lot of these devices.
Quantity in Commerce519,676 units
DistributionDistribution US Nationwide, Australia and Canada
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FMI
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