—#109371

Product

Monoject Insulin Safety Syringe 1/2mL 30 X 5/16" Product ID: 8881511336 Indications for Use: Injection of U-1 00 insulin

FDA product code: FMF — Syringe, Piston
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K922522
Affected lot / code info: Lot Codes: 015605, 034606, 019114

Why it was recalled

Safety shield may separate from the syringe, exposing the needle, which could potentially result in a needle stick

Root cause (FDA determination)

Equipment maintenance

Action the firm took

Covidien sent an Urgent Product Recall letter dated May 21, 2012, via Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately stop using any affected product. Distributors were requested to notify their customers. Customers were instructed to complete the Monoject Insulin Safety Syringe recalled product return form even if they have no product to return. The form should be faxed to 1-800-895-6140 or e-mailed to sdfeedback@covidien.com. Customer Service questions regarding the recall please use one of the following methods. Telephone:1-800-722-8772 option I (Weekdays, 8am to 6:30pm Eastern) e-mail:sdfeedback@covidien.com

Recalling firm

Firm: Covidien LLC
Address: 15 Hampshire Street, Mansfield, Massachusetts 02048-1113

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and the countries of Canada, Australia, Belgium, and Panama.

Timeline

Recall initiated: 2012-05-21
Posted by FDA: 2012-05-31
Terminated: 2013-06-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #109371. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.