Z-2462-2008

Quick Connect component p/n 201048. The component is contained in QPC1713 and QPC1724 Quick Connects. The...

Name: Z-2462-2008 Quick Connect component p/n 201048. The component is contained in QPC1713 and QPC1724 Quick Connects. The...
Creator: Steris Corp
Published: 2008-08-04
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2008-08-04 / Terminated / root cause: design

FDA source

Steris Corp began a recall of Quick Connect component p/n 201048. The component is contained in QPC1713 and QPC1724 Quick Connects. The QPC1724 is used to attach Pentax... on 2008-08-04. The reason FDA records is "During ongoing product development testing, it was discovered that, when the two inflow barbs on adapter 201048 # 4 are in a position to face one direction, the top Barblock may interfere with the top surface of bottom...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2462-2008
Status: Terminated
Initiated: 2008-08-04
Posted: 2008-09-23
Terminated: 2013-02-26
Recalling firm: STERIS Corporation
Product: Quick Connect component p/n 201048. The component is contained in QPC1713 and QPC1724 Quick Connects. The QPC1724 is used to attach Pentax 70/70K/72/72K/80K/81K/90i/90K SERIES GI ENDOSCOPES WITH WATER JET to the C1160 Universal Flexible Processing Tray in the SYSTEM 1 Sterile Processing System. The QPC1713 is used to attach Pentax 70/70K/80K/85/85K/90K SERIES GI ENDOSCOPES without WATER JET to the C1160 Universal Flexible Processing Tray in the SYSTEM 1 Sterile Processing System.
Product code: MED Sterilant, Medical Devices
Reason for recall: During ongoing product development testing, it was discovered that, when the two inflow barbs on adapter 201048 # 4 are in a position to face one direction, the top Barblock may interfere with the top surface of bottom barb of the adapter. The interference may cause the plunger on the suction side to lift slightly which may affect flow of sterilant into the suction lumen.
Root cause tag: design
FDA root cause: Device Design
Action: A Steris Field Service Representative will make arrangements to visit each facility to modify the affected Quick Connects. Until that time customers may use the work around instructions for use in the notification letter dated August 4, 2008. Contact Steris Corporation at 1-800-548-4873 or 1-440-392-7455 for assistance.
Quantity in commerce: QPC1713 Quick Connects - 116 units & QPC1724 Quick Connects - 568 units
Distribution: AK, AL, AR, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TX, VA, VT, WI, WV and WY. OUS: Canada, Australia, Italy, Spain, and Thailand.
Product codes and lots: QPC1713 Model # QFC1728; Serial #: 3870300, 3870367, 3870326, 3870342, 3923281, 3954195, 4008389, 4045720, 4091419, 4153292, 4201828, 4274429, 4297354, 4247052, C601846, C601879, 4569117, 4710430, 4770715, 4862314, 4899068, 4942173, 5005517, 5098421, and 5261433. QPC1724 Model # QFC1729; Serial # 3500782, 3531266, 3614856, 3644010, 3681319, 3753928, 3753944, 3754231, 3864709, 3865110, 3879319, 3935418, 3962214, 3967825, 4054979, 4123873, 4186201, C601848, 4274445, 4363339, 4247078, 4479853, 4588679, 4632667, 4684007, 4738753, 4802294, 4810867, 4869749, 4899084, 4942199, 4952487, 4987020, 5026513, 5063789, 5098447, 5159215, 5211669, 5256367, and 5257266

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)