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U.S. Department of Health and Human Services

Class 2 Device Recall CLINITRON CII

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 Class 2 Device Recall CLINITRON CIIsee related information
Date Initiated by FirmMay 05, 2003
Date PostedJuly 10, 2003
Recall Status1 Terminated 3 on July 26, 2004
Recall NumberZ-0989-03
Recall Event ID 26486
510(K)NumberK813584 
Product Classification Bed, Air Fluidized - Product Code INX
ProductCLINITRON CII Air Fluidized Therapy unit.
Code Information Model CII, Serial #CC(all numeric codes).
FEI Number 1045510
Recalling Firm/
Manufacturer		 Hill-Rom Manufacturing, Inc.
4349 Corporate Road
Charleston SC 29405
For Additional Information ContactMark Lanning
843-740-8586
Manufacturer Reason
for Recall		Malfunction of side-rail latching pin coupled with inadequate directions for use.
FDA Determined
Cause 2		Other
ActionConsignees were notified by letter sent via Airborne express, on May 5, 2003. Side-rail latching pins will be replaced with a more robust version. Label indicating directions for use will be modified to include detailed information on proper procedures for moving the units.
Quantity in Commerce122 units (including both units)
DistributionThe units are primarily leased to hospitals. Units have been sold to hospitals located nationwide and to Canada, Austria, France, Germany Ireland Italy, Netherlands, Spain, Sweden, Switzerland and the United Kingdom.
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = INX
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