Class 2 Device Recall CLINITRON CII

• Date Initiated by Firm: May 05, 2003
• Date Posted: July 10, 2003
• Recall Status: Terminated on July 26, 2004
• Recall Number: Z-0989-03
• Recall Event ID: 26486
• 510(K)Number: K813584
• Product Classification: Bed, Air Fluidized - Product Code INX
• Product: CLINITRON CII Air Fluidized Therapy unit.
• Code Information: Model CII, Serial #CC(all numeric codes).
• Recalling Firm/ Manufacturer: Hill-Rom Manufacturing, Inc.; 4349 Corporate Road; Charleston SC 29405
• For Additional Information Contact: Mark Lanning; 843-740-8586
• Manufacturer Reason for Recall: Malfunction of side-rail latching pin coupled with inadequate directions for use.
• FDA Determined Cause: Other
• Action: Consignees 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 Commerce: 122 units (including both units)
• Distribution: The 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 Cycle: TPLC 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) Database: 510(K)s with Product Code = INX and Original Applicant = UHI CORP.