Recall Z-1868-2018

Richard Wolf GmbH · initiated March 11, 2018

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endoscopic microsurgery.

Codes / lots: Lot numbers: 32062417, 32133317

Reason for recall

Tube ends may be mixed up.

FDA-determined 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.

Details

Recall number
Z-1868-2018
Initiated
March 11, 2018
Terminated
March 9, 2022
Product code
HIF – Insufflator, Laparoscopic
Quantity
1710 units
Distribution
Worldwide Distribution
Recalling firm
Richard Wolf GmbH, Knittlingen

Official FDA recall record