McKesson PREVENT M NEEDLE (Magellan Technology) 25G X 5/8". 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: 26558
- Company
- Cardinal Health
- Recall Initiated
- February 9, 2021
- Terminated
- April 9, 2024
- Recall Number
- Z-1251-2021
- Quantity
- 108,000 units
- Firm Location
- Mansfield, MA
Reason for Recall
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
Distribution
Worldwide distribution - US Nationwide distribution and the countries of AE, Japan.
Lot / Code Info
Lot Code: 028603
Root Cause
Equipment maintenance
Action Taken
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. 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 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. 6. Customers that did not receive product directly from Cardinal Health should return product through the location where they purchased it. Contact Cardinal Health at 800-292-9332.