Z-0967-2007

Steris QFC1728 and QFC1729 Quick Connects used in connections and processing endoscopes. The QFC1728 is used...

Name: Z-0967-2007 Steris QFC1728 and QFC1729 Quick Connects used in connections and processing endoscopes. The QFC1728 is used...
Creator: Steris Corp
Published: 2007-02-23
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2007-02-23 / Terminated / root cause: manufacturing process

FDA source

Steris Corp began a recall of Steris QFC1728 and QFC1729 Quick Connects used in connections and processing endoscopes. The QFC1728 is used to process the Fujinon 250/270/450/470/490 Group 5... on 2007-02-23. The reason FDA records is "The center insert of the adaptor #6 restrictor could become loose and/or come out of the housing and 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-0967-2007
Status: Terminated
Initiated: 2007-02-23
Posted: 2007-06-21
Terminated: 2012-03-01
Recalling firm: STERIS Corporation
Product: Steris QFC1728 and QFC1729 Quick Connects used in connections and processing endoscopes. The QFC1728 is used to process the Fujinon 250/270/450/470/490 Group 5 and 530/590 series GI Endoscopes w/o Water Jet. The QFC1729 is used to process 250/450 Group 5 and 530/590 series Endoscopes w/ Water Jet.
Product code: MED Sterilant, Medical Devices
Reason for recall: The center insert of the adaptor #6 restrictor could become loose and/or come out of the housing and may affect the sterilization process of the attached endoscope
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On February 22, 2007, customers were contacted by phone and were notified by recall letter dated February 23, 2007. The recall notifications indicate that Steris Account managers will visit each consignee and replace affect product.
Quantity in commerce: 146
Distribution: Worldwide-The product was distributed to USA domestic consignees located in MT, CA, NJ, IA, MA, WY, SC, MO, SC, TN, ID, MT, CO, PA, NV, and TX, and to foreign consignees located in Great Britian and Qatar.
Product codes and lots: Lot numbers: 2914737, 2876316, 2871200, 2876274, 2914752, 2876704, 2876720, 2876746, 2876761, 3072030, and 3072014.

Product code MED

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)