Z-0424-2021Class II

Covidien MONOJECT Standard Hypodermic Needle, Polypropylene Hub 22 G x 3/4". Intended use to facilitate...

Name: Z-0424-2021 Covidien MONOJECT Standard Hypodermic Needle, Polypropylene Hub 22 G x 3/4". Intended use to facilitate...
Creator: Cardinal Health 200, LLC
Published: 2020-09-25
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2020-09-25 / Terminated

FDA source

Cardinal Health 200, LLC began a recall of Covidien MONOJECT Standard Hypodermic Needle, Polypropylene Hub 22 G x 3/4". Intended use to facilitate activities such as: withdrawal of medication from a... on 2020-09-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0424-2021
Classification: Class II
Status: Terminated
Initiated: 2020-09-25
Posted: 2020-11-05
Terminated: 2023-10-30
Recalling firm: Medtronic, Inc.
Product: 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
Product code: FMI Needle, Hypodermic, Single Lumen
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 root cause: Under Investigation by 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.
Quantity in commerce: 519,676 units
Distribution: Distribution US Nationwide, Australia and Canada
Product codes and lots: Lot Number: 011144 Expanded Recall 11/4/20: Lot Number: 011145

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0424-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0424-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-11	2020-11-05

Product code FMI

K854547Class IIMonoject Sterile M200 Aluminum/m250 PolypropyleneSherwood Medical Co. / cleared 1986-02-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)