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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmJune 20, 2003
Date PostedJuly 18, 2003
Recall Status1 Terminated 3 on December 19, 2003
Recall NumberZ-1027-03
Recall Event ID 26586
ProductHill-Rom Newborn bassinet; model P247
Code Information All units distributed from November 2000 through April 2003.
Recalling Firm/
Manufacturer
Hill-Rom, Inc.
125 E Pearl St
Batesville IN 47006
For Additional Information Contact
812-934-7777
Manufacturer Reason
for Recall
The caster/wheel may come off of the bassinet, causing the bassinet to tip.
FDA Determined
Cause 2
Other
ActionCustomer notification letters dated June 20, 2003 were sent to each customer. Customers are asked to verify the security of the casters to the base and to visually check for loose or missing caster screws, to remove any bassinets from service until repaired, and that Hill-Rom will visit each customer to replace the caster screws on all units.
Quantity in Commerce1,501
DistributionUnited States, Brazil, Canada, China, Italy, Japan, Kuwait Netherlands, Qatar, United Kingdom

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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