Device product
Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E. STERIS Corporation, Mentor, OH 44060 QLC1677E, QRC1699E, QPC1721E and QFC1683E contain processing instructions, a Quick Reference Wall Chart and a flow unit. The flow unit consists of a Quick Reference Card, tubing, tethers and adapters for connecting specified devices to Flexible Processing Trays/Containers.
Z-1596-2013
Product summary
- Event
- Event 65138
- Status
- Terminated
- Classification
- Class II
- Quantity
- QLC1677E: 38; QRC1699E: 128 & QPC1721E/QFC1683E: 0
- Official record key
device-enforcement:Z-1596-2013
Official wording
Reason: During a routine label review, the firm identified four SYSTEM 1E Quick Connects that will be updated to reflect the removal of obsolete device models. This labeling review process also highlighted the opportunity to combine two existing quick connects into a single product while eliminating the obsolete models.
Code information: LOT NUMBERS: QLC1677E: 1986157 - 2740157; QRC1699E: 1953884- 3376282 & QPC1721E/ QFC1683E: 3809423-Q001121.
Distribution pattern: Nationwide Distribution including the states of AK, AZ, CA, CO, FL, IL, IN, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NY, OH, OK, OR, PA, SD, TN, TX, VA, WA, WI and WY.
Derived failure modes
-
Unknown
During a routine label review, the firm identified four SYSTEM 1E Quick Connects that will be updated to reflect the removal of obsolete device models. This labeling review process also highlighted the opportunity to combine two existing quick connects into a single product while eliminating the obsolete models.