Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, OR Packaged, Sterile Item Code: 17099
This recall has been terminated (originally issued October 14, 2016).
- Company
- Covidien Llc
- Recall Initiated
- October 14, 2016
- Terminated
- August 8, 2018
- Recall Number
- Z-0756-2017
- Quantity
- 5,187,100 Units
- Firm Location
- North Haven, CT
- Official Source
- View on FDA website ↗
Reason for Recall
Sterility of the outer surface of the container compromised due to packaging defect.
Distribution
Nationwide Foreign: Japan
Lot / Code Info
All lots starting with 3, 4, 5 and all lots from 600586264X to 613480164X
Root Cause
Packaging process control
Action Taken
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.