—#185796

Product

Magellan 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: 8881850558

FDA product code: FMI — Needle, Hypodermic, Single Lumen
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: Lot Code: 025221

Why it was recalled

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 (FDA determination)

Equipment maintenance

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution - US Nationwide distribution and the countries of AE, Japan.

Timeline

Recall initiated: 2021-02-09
Terminated: 2024-04-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #185796. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.