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U.S. Department of Health and Human Services

Medical Devices

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Infant Bassinet

Class I Recall

The following information relates to FDA's decision to issue a Class I recall for this product.

Date Recall Initiated
 March 20, 2002
Product:
 Bassinets with drop leaf work surface, models 248 and 1251
Use:
 Used in hospital infant care environments as pediatric beds.
Recalling Firm:
 Hill-Rom, Inc.
1069 State Rt. 46
East Batesville, IN 47006
Reason for Recall:
 Although the drop leaf shelf is not intended as a support shelf for infants, when used in this manner, the drop leaf shelf support mechanism will fail to support the infant. The infant could fall causing head or other bodily injury.
Public Contact:
 Mr. Les Schnoll
Director, Corporate Regulatory Management
Phone: 812-934-7599
FDA District:
 Detroit, Michigan
FDA Comment:
 FDA considers there to be a risk of serious injury from continued use of this device until the correction is made.

 

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