Z-0989-03

CLINITRON CII Air Fluidized Therapy unit

Name: Z-0989-03 CLINITRON CII Air Fluidized Therapy unit
Creator: Hill-Rom Manufacturing, Inc.
Published: 2003-05-05
License: https://open.fda.gov/license/

Hill-Rom Manufacturing, Inc. / initiated 2003-05-05 / Terminated

FDA source

Hill-Rom Manufacturing, Inc. began a recall of CLINITRON CII Air Fluidized Therapy unit on 2003-05-05. The reason FDA records is "Malfunction of side-rail latching pin coupled with inadequate directions for use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0989-03
Status: Terminated
Initiated: 2003-05-05
Posted: 2003-07-10
Terminated: 2004-07-26
Recalling firm: Hill-Rom Manufacturing, Inc.
Product: CLINITRON CII Air Fluidized Therapy unit.
Product code: INX Bed, Air Fluidized
Reason for recall: Malfunction of side-rail latching pin coupled with inadequate directions for use.
FDA root 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.
Product codes and lots: Model CII, Serial #CC(all numeric codes).

Product code INX

K813584Class IIClinitron Air Fluidized Support SystemUhi Corp. / cleared 1982-01-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)