The following information relates to FDA's decision to issue a Class I recall for this product. Additional information about Class I Medical Device Recalls can be found on the CDRH Recall Page.
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Date Recall
Initiated |
March 20, 2002 |
|---|---|
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Product:
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Bassinets with drop leaf work surface, models 248 and 1251 |
|
Use:
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Used in hospital infant care environments as pediatric beds. |
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Recalling Firm:
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Hill-Rom, Inc. 1069 State Rt. 46 East Batesville, IN 47006 |
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Reason for Recall:
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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. |
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Public Contact:
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Mr. Les Schnoll Director, Corporate Regulatory Management Phone: 812-934-7599 |
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FDA District:
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Detroit, Michigan |
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FDA Comment:
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FDA considers there to be a risk of serious injury from continued use of this device until the correction is made. |
For additional information on this product recall, see the FDA Enforcement Report locate at: http://www.fda.gov/bbs/topics/enforce/2002/ENF00741.html. Scroll down to "Recalls and Field Corrections: Device - Class 1"
Updated July 10, 2002
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