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Terminated

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

FDA Recall Z-1868-2018 · Posted None

Recalling FirmRichard Wolf GmbH
Recall StatusTerminated
Product CodeHIF
Date Initiated2018-03-11
Date Terminated2022-03-09
Product Quantity1710 units

Reason for Recall

Tube ends may be mixed up.

Firm 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 [email protected].

Root Cause

Use error

Distribution Pattern

Worldwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K000180TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOPRichard Wolf Medical Instruments Corp. · 2001-03-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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