Recall Z-0756-2017 ยท FMH Container, Specimen, Sterile
Covidien LLC
Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, OR Packaged, Sterile Item Code: 17099
| Date | Oct 14, 2016 |
| Status | Terminated |
| Reason | Sterility of the outer surface of the container compromised due to packaging defect. |
| Root cause | 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 | 5,187,100 Units |
| Distribution | Nationwide Foreign: Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.