Monoject Insulin Safety Syringe 1/2mL 30 X 5/16" Product ID: 8881511336 Indications for Use: Injection of U-1 00 insulin
FDA Recall Z-1697-2012 · Posted 2012-05-31
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Recalling FirmCovidien LLC
Recall StatusTerminated
Product CodeFMF
Date Initiated2012-05-21
Date Terminated2013-06-10
Product Quantity385,000 syringes
Reason for Recall
Safety shield may separate from the syringe, exposing the needle, which could potentially result in a needle stick
Firm Action
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 [email protected].
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:[email protected]
Root Cause
Equipment maintenance
Distribution Pattern
Worldwide Distribution - USA (nationwide) and the countries of Canada, Australia, Belgium, and Panama.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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