Recall Z-1868-2018 ยท HIF Insufflator, Laparoscopic
Richard Wolf GmbH
RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endoscopic microsurgery.
| Date | Mar 11, 2018 |
| Status | Terminated |
| Reason | Tube ends may be mixed up. |
| Root cause | Use error |
| Action | The firm initiated the recall via an Urgent Safety Information letter on 03/11/2018. The letter identified the affected product and the problem involved. Customers were asked to check the inventory for the affected lot numbers and complete the attached answer form. The firm requested that the recalled product be discarded. All users should be notified of the safety information. The completed answer form should be returned via fax to 07043 354467 or e-mail to marek.rast@richard-wolf.com. |
| Quantity | 1710 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000180 | TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP Richard Wolf Medical Instruments Corp., Mar 2, 2001 |