Recall Z-1252-2021 ยท FMI Needle, Hypodermic, Single Lumen
Cardinal Health 200, LLC
Magellan 3 mL Syringe with Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. Product Code: 8881833558
| Date | Feb 9, 2021 |
| Status | Terminated |
| Reason | Safety shield not locking into the cannula. If the safety shield activation fails to lock a contaminated needle, a needlestick may occur and there is the potential for exposure to bloodborne pathogens |
| Root cause | Equipment maintenance |
| Action | Cardinal Health issued Urgent Medical Device Recall letter on 2/9/21via 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 for examples). 2. SEGREGATE and QUARANTINE all on-hand affected product. 3. PLEASE RETURN the enclosed acknowledgment form via facsimile (614-652-9648) or email (GMB-FieldCorrectiveAction@cardinalhealth.com) and indicate the product code, lot and quantity of product youve quarantined. Please respond regardless of whether or not you have affected product. 4 |
| Quantity | 6800 units |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of AE, Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012736 | MONOJECT SAFETY NEEDLE Tyco Healthcare, Oct 25, 2001 |