Fetzer Medical GmbH & Co. KG: The firm had a report of doctors being unable to pull the obstetric forceps apart.

Agency Publication Date: January 18, 2019

Affected Products

Product: 16600 / Fetzer Surgical Luikart Simpson OB Forceps14" (35.5cm), Item No./Product Code 46-5050 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.

Lot Numbers: 17302220, 17303061, 17303062 and 17303063

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Product: 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.

Lot Number 13300828

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Product: 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.

Lot Number 18800612

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Product: 12002 / Boss Instruments Simpson OB Forceps, short model, 13" (33cm), Item No./Product Code 46-5040 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.

Lot Number 13300956

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Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81873

Status: Resolved

Manufacturer: Fetzer Medical GmbH & Co. KG

Manufactured In: Germany

Units Affected: 4 products (174 units; 10 units; 10 units; 2 units)

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Sources: FDA iRES · Raw API Response

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Affected Products

Lot Numbers: 17302220, 17303061, 17303062 and 17303063

Lot Numbers:

Numbers

Lot Number 13300828

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Number

Lot Number 18800612

Lot Numbers:

Number

Lot Number 13300956

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Number