Recall Z-2538-2017 ยท FZX Guide, Surgical, Instrument
Cook Inc.
Endoscopic Introducer/Extractor
| Date | Apr 25, 2017 |
| Status | Terminated |
| Reason | reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products |
| Root cause | Labeling design |
| Action | On 4/25/2017, URGENT: MEDICAL DEVICE RECALL notifications were sent to the affected consignees via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. |
| Quantity | 46 |
| Distribution | The devices have been distributed nationwide within the United States and the following countries: Australia, Belgium, Canada, Finland, Germany, Guatemala, Hong Kong, India, Ireland, Japan, South Korea, Kuwait, Malaysia, Netherlands, New Zealand, Puerto Rico, Saudi Arabia, Taiwan, and the United Kin |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.