—#184015

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

FDA product code: FMI — Needle, Hypodermic, Single Lumen
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K854547
Affected lot / code info: Lot Number: 011144 Expanded Recall 11/4/20: Lot Number: 011145

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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 (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.

Recalling firm

Firm: Cardinal Health
Address: 200 LLC 15 Hampshire St, Bldg 5, Mansfield, Massachusetts 02048-1113

Distribution

Distribution pattern: Distribution US Nationwide, Australia and Canada

Timeline

Recall initiated: 2020-09-25
Terminated: 2023-10-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #184015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.