Z-0547-03

C1406, QLC1406, C1473, and QLC1473 Quick Connect for Olympus 30/40/160/200/240 Series Bronchoscopes in the...

Name: Z-0547-03 C1406, QLC1406, C1473, and QLC1473 Quick Connect for Olympus 30/40/160/200/240 Series Bronchoscopes in the...
Creator: Steris Corp
Published: 2003-03-07
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2003-03-07 / Terminated / root cause: sterility

FDA source

Steris Corp began a recall of C1406, QLC1406, C1473, and QLC1473 Quick Connect for Olympus 30/40/160/200/240 Series Bronchoscopes in the C1140 Universal Processing Trays. Catalog numbers... on 2003-03-07. The reason FDA records is "The Steris device may not attach properly to retrofitted Olympus bronchoscopes, and become loose during the sterile processing cycle". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0547-03
Status: Terminated
Initiated: 2003-03-07
Posted: 2003-02-06
Terminated: 2004-02-05
Recalling firm: STERIS Corporation
Product: C1406, QLC1406, C1473, and QLC1473 Quick Connect for Olympus 30/40/160/200/240 Series Bronchoscopes in the C1140 Universal Processing Trays. Catalog numbers: C11473 and QLC1473.
Product code: MLR Sterilizer, Chemical
Reason for recall: The Steris device may not attach properly to retrofitted Olympus bronchoscopes, and become loose during the sterile processing cycle.
Root cause tag: sterility
FDA root cause: Other
Action: On 3/14/2002 by mail and 2/21/2003 by fax. The units will be replaced.
Quantity in commerce: 1,140 units
Distribution: Nationwide. Some foreign distribution into Canada, Italy, Greece, Australia, New Zealand, UK, Brussels, Norway, Zaire, Spain, Behrain, Israel.
Product codes and lots: Lot nos: 3508686 or smaller (C1406 and QLC1406); Lot nos: 3147303 or smaller (C1473 and QLC1473).

Product code MLR

K875280Class IISteris System 1 Processor and 20 SterilantSteris C/O Medical Device Consultants, Inc. / cleared 1988-09-13

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)