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Terminated

Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, OR Packaged, Sterile Item Code: 17099

FDA Recall Z-0756-2017 · Posted None

Recalling FirmCovidien LLC
Recall StatusTerminated
Product CodeFMH
Date Initiated2016-10-14
Date Terminated2018-08-08
Product Quantity5,187,100 Units

Reason for Recall

Sterility of the outer surface of the container compromised due to packaging defect.

Firm Action

Covidien initiated recall by letter on October 14, 2016. Customers were notified via Federal Express and the letter instructs customers to discontinue use of the product and return all inventory of the affected lots to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. Accounts requested to completed Recalled Product Return From to obtain an RGA. Questions: Contact your Medtronic representative or Customer Service at (800) 882-5878.

Root Cause

Packaging process control

Distribution Pattern

Nationwide Foreign: Japan

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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