Fetzer De Lee Obstetric Forceps Recalled Due to Functional Defect
Fetzer Medical is recalling 10 units of De Lee Obstetric Forceps because doctors reported being unable to pull the instruments apart.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect that could compromise patient safety during a high-risk procedure, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Fetzer Medical GmbH & Co. KG is recalling 10 units of the 16600 / Fetzer Surgical De Lee Obstetric Forceps, 11" (30cm), Item No./Product Code 46-5034. The recall is limited to Lot Number 18800612. These instruments are hand-held devices intended to assist in difficult vaginal births by grasping the fetal head.
The recall was initiated after the firm received a report that doctors were unable to pull the obstetric forceps apart. This functional defect could prevent the proper use of the instrument during a medical procedure.
The affected units were distributed in the United States to the states of Illinois and Virginia. Consumers and healthcare providers should stop using the recalled forceps and contact the manufacturer for instructions on return or replacement.
The recalled product
- 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 faci
- Manufacturer
- Fetzer Medical GmbH & Co. KG
- Hazard
- Affected units
- 10
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number 18800612
Distribution
Part of a larger recall action
This product is one of 4 recalled by Fetzer Medical GmbH & Co. KG under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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