Recalls / —

—#173132

Product

Monoject Standard Hypodermic Needle Item code: 8881200029

FDA product code

FMI — Needle, Hypodermic, Single Lumen

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K854547

Affected lot / code info

Lot Number: 904956

Why it was recalled

Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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 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. Questions 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

Nationwide Foreign: AU, BE, CA, DK, FI, GB, IE, NL

Timeline

Recall initiated

2019-04-30

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #173132. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.