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U.S. Department of Health and Human Services

Class 2 Device Recall Covidien Precision Specimen Container

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  Class 2 Device Recall Covidien Precision Specimen Container see related information
Date Initiated by Firm October 14, 2016
Create Date December 14, 2016
Recall Status1 Terminated 3 on August 08, 2018
Recall Number Z-0756-2017
Recall Event ID 75481
Product Classification Container, specimen, sterile - Product Code FMH
Product Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, OR Packaged, Sterile
Item Code: 17099
Code Information All lots starting with 3, 4, 5 and all lots from 600586264X to 613480164X
Recalling Firm/
Covidien LLC
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information Contact
Manufacturer Reason
for Recall
Sterility of the outer surface of the container compromised due to packaging defect.
FDA Determined
Cause 2
Packaging process control
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.
Quantity in Commerce 5,187,100 Units
Distribution Nationwide Foreign: Japan
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.