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Terminated

QPC1680 Quick Connect, for Pentax 30/40/K Series Two-Channel GI Endoscopes, in the Steris System 1 Sterile Processing System with the C1160 Universal Flexible Processing Tray, Cat No. QPT1680

FDA Recall Z-0765-04 · Posted 2004-07-20

Recalling FirmSteris Corp
Recall StatusTerminated
Product CodeMED
Date Initiated2004-03-15
Date Terminated2004-05-18
Product Quantity40 units

Reason for Recall

A defective port adapter may affect the sterilization process of the attached endoscope.

Firm Action

The firm contacted the consignees by letter and in person.

Root Cause

Process control

Distribution Pattern

The product was shipped to domestic consignees in LA, NC, OH, CT, VA, CA, ME, MD, IL, PA, SC, WY, ND, NY, OK, TX. Foreign distribution involves: Canada, Italy, and Germany.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K875280STERIS SYSTEM 1 PROCESSOR AND 20 STERILANTSteris C/O Medical Device Consultants, Inc. · 1988-09-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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