Fetzer Medical Recalls Wrigley Obstetric Forceps Due to Functional Defect
Fetzer Medical is recalling 10 units of Wrigley Obstetric Forceps because doctors reported being unable to pull the instruments apart.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 (inability to open) that poses a risk of harm during a medical procedure, but no injuries or illnesses have been reported.
Plain-English summary
Fetzer Medical GmbH & Co. KG is recalling 10 units of Wrigley Obstetric Forceps, 11" (28cm), Item No./Product Code 46-5004. The recall was initiated after the firm received a report that doctors were unable to pull the obstetric forceps apart.
The affected products are identified by Lot Number 13300828. These instruments are hand-held devices intended to assist the birth of a foetus during difficult vaginal births by grasping the foetal head. The products were distributed in the United States to the states of Illinois and Virginia.
Healthcare providers and consumers should stop using the affected forceps immediately and contact the recalling firm for instructions on return or replacement.
The recalled product
- 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…
- 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 13300828
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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