Fetzer Medical GmbH & Co. KG recalls 16600 / Fetzer Surgical De Lee Obstetric Forceps, 11" (30cm), Item No./Product Code 46-5034 Fetzer Medical Obstetrical…

Recall date

December 28, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0757-2019

FDA classification

Class II

Brand / firm

Fetzer Medical GmbH & Co. KG

Sold / distributed

US Distribution to states of: IL and VA.

Why it was recalled

The firm had a report of doctors being unable to pull the obstetric forceps apart.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

16600 / Fetzer Surgical De Lee Obstetric Forceps, 11" (30cm), Item No./Product Code 46-5034 Fetzer Medical Obstetrical Forceps is a hand-held instruments intended to assist the birth of a foetus during difficult vaginal births through grasping the foetal head in order to facilitate its passage through the birth canal. The instruments are only used for female population. The product is non-powder, non-liquid, non-tablet, capsule or other.