Covidien 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
FDA Recall Z-0424-2021 · Posted None
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Recalling FirmCardinal Health 200, LLC
Recall StatusTerminated
Product CodeFMI
Date Initiated2020-09-25
Date Terminated2023-10-30
Product Quantity519,676 units
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
Firm Action
Cardinal 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 ([email protected]) 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.
Root Cause
Under Investigation by firm
Distribution Pattern
Distribution US Nationwide, Australia and Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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