Z-1868-2018 Class II Terminated
FDA device recall Z-1868-2018 was initiated by Richard Wolf GmbH on March 11, 2018 and is designated Class II. Reason for recall: Tube ends may be mixed up. The recall status is terminated (terminated March 9, 2022). Affected quantity: 1710 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 23, 2018
- Initiation Date
- March 11, 2018
- Termination Date
- March 9, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1710 units
Product Description
RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endoscopic microsurgery.
Reason for Recall
Tube ends may be mixed up.
Distribution Pattern
Worldwide Distribution
Code Information
Lot numbers: 32062417, 32133317