Quick Connect component p/n 201048. The component is contained in QPC1713 and QPC1724 Quick Connects. The QPC1724 is use
FDA device recall Z-2462-2008 · posted 2008-09-23 · Terminated
Recall details
- Recalling firm
- Steris Corp
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MED
- Quantity affected
- 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, Sp
- Date initiated
- 2008-08-04
- Date posted
- 2008-09-23
- Date terminated
- 2013-02-26
- Location
- Mentor, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STERIS SYSTEM 1 PROCESSOR AND 20 STERILANT (K875280) | Steris C/O Medical Device Consultants, Inc. | 1988-09-13 |