RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endoscopic microsurgery.
This recall has been terminated (originally issued March 11, 2018).
- Recall Initiated
- March 11, 2018
- Terminated
- March 9, 2022
- Recall Number
- Z-1868-2018
- Quantity
- 1710 units
- Official Source
- View on FDA website ↗
Reason for Recall
Tube ends may be mixed up.
Distribution
Worldwide Distribution
Lot / Code Info
Lot numbers: 32062417, 32133317
Root Cause
Use error
Action Taken
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.