12002 / Boss Instruments Ltd. Wrigley Obstetric Forceps, 11" (28cm), Item No./Product Code 46-500...
FDA Recall #Z-0756-2019 — Class II — December 28, 2018
Product Description
12002 / Boss Instruments Ltd. Wrigley Obstetric Forceps, 11" (28cm), Item No./Product Code 46-5004 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.
Reason for Recall
The firm had a report of doctors being unable to pull the obstetric forceps apart.
Recalling Firm
Fetzer Medical GmbH & Co. KG — Tuttlingen, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
10 units
Distribution
US Distribution to states of: IL and VA.
Code Information
Lot Number 13300828
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated