Recalls / —

—#150473

Product

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

FDA product code

FMH — Container, Specimen, Sterile

Device class

Class 1

Medical specialty

Pathology

Affected lot / code info

All lots starting with 3, 4, 5 and all lots from 600586264X to 613480164X

Why it was recalled

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

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm

Covidien LLC

Address

60 Middletown Ave, North Haven, Connecticut 06473-3908

Distribution

Distribution pattern

Nationwide Foreign: Japan

Timeline

Recall initiated

2016-10-14

Terminated

2018-08-08

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #150473. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.