Recall Z-2040-2019 ยท FMI Needle, Hypodermic, Single Lumen
Cardinal Health 200, LLC
Monoject Standard Hypodermic Needle, 18 G x 1-1/2" Item code: 8881200078
| Date | Apr 30, 2019 |
| Status | Completed |
| Reason | Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product |
| Root cause | Under Investigation by firm |
| Action | Cardinal Health issued notification letter by mail on 4/30/19 advising product defect, health risk and action to take: 1. INSPECT inventory for the affected 2. SEGREGATE and QUARANTINE all on-hand product; 3. RETURN acknowledgment form via fax to 847-689-9101 or 614-652-9648, whether or not you have affected product, indicating the product code, lot and quantity of product quarantined or discarded. 4. NOTIFY any customers to whom you may have distributed, or forwarded product affected by this recall. Your notification to your customers may be enhanced by including a copy of this recall notifi |
| Distribution | Nationwide Foreign: AU, BE, CA, DK, FI, GB, IE, NL |
| 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 |