Recall Z-0424-2021 ยท FMI Needle, Hypodermic, Single Lumen
Cardinal Health 200, LLC
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
| Date | Sep 25, 2020 |
| Status | Terminated |
| Reason | 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 | 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 (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 |
| Quantity | 519,676 units |
| Distribution | Distribution US Nationwide, Australia and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K854547 | MONOJECT STERILE M200 ALUMINUM/M250 POLYPROPYLENE Sherwood Medical Co., Feb 4, 1986 |