Z-0765-04

QPC1680 Quick Connect, for Pentax 30/40/K Series Two-Channel GI Endoscopes, in the Steris System 1 Sterile...

Name: Z-0765-04 QPC1680 Quick Connect, for Pentax 30/40/K Series Two-Channel GI Endoscopes, in the Steris System 1 Sterile...
Creator: Steris Corp
Published: 2004-03-15
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2004-03-15 / Terminated / root cause: manufacturing process

FDA source

Steris Corp began a recall of QPC1680 Quick Connect, for Pentax 30/40/K Series Two-Channel GI Endoscopes, in the Steris System 1 Sterile Processing System with the C1160 Universal Flexible... on 2004-03-15. The reason FDA records is "A defective port adapter may affect the sterilization process of the attached endoscope". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0765-04
Status: Terminated
Initiated: 2004-03-15
Posted: 2004-07-20
Terminated: 2004-05-18
Recalling firm: STERIS Corporation
Product: QPC1680 Quick Connect, for Pentax 30/40/K Series Two-Channel GI Endoscopes, in the Steris System 1 Sterile Processing System with the C1160 Universal Flexible Processing Tray, Cat No. QPT1680
Product code: MED Sterilant, Medical Devices
Reason for recall: A defective port adapter may affect the sterilization process of the attached endoscope.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm contacted the consignees by letter and in person.
Quantity in commerce: 40 units
Distribution: The product was shipped to domestic consignees in LA, NC, OH, CT, VA, CA, ME, MD, IL, PA, SC, WY, ND, NY, OK, TX. Foreign distribution involves: Canada, Italy, and Germany.
Product codes and lots: Lots #2925196, #2911782, #2925238.

Product code MED

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)