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U.S. Department of Health and Human Services

Class 2 Device Recall Quick Connect

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  Class 2 Device Recall Quick Connect see related information
Date Initiated by Firm August 04, 2008
Date Posted September 23, 2008
Recall Status1 Terminated 3 on February 26, 2013
Recall Number Z-2462-2008
Recall Event ID 49390
510(K)Number K875280  
Product Classification Barblocks - 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 OH 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		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MED and Original Applicant = STERIS C/O MEDICAL DEVICE CONSULTANTS, INC.
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