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U.S. Department of Health and Human Services

Class 2 Device Recall Quick Connect

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 Class 2 Recall
Quick Connect
see related information
Date Posted September 23, 2008
Recall Status1 Open
Recall Number Z-2462-2008
Recall Event ID 49390
Premarket Notification
510(K) Number
K875280 
Product Classification Sterilant, Medical Devices - Product Code MED
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.
Code Information 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
Recalling Firm/
Manufacturer
Steris Corp
5960 Heisley Rd
Mentor, Ohio 44060-1834
For Additional Information Contact Rosemary Niewolak
440-392-7455
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MED and Original Applicant = STERIS C/O MEDICAL DEVICE CONSULTANTS, INC.
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