QPC1680 Quick Connect, for Pentax 30/40/K Series Two-Channel GI Endoscopes, in the Steris System 1 Sterile Processing Sy
FDA device recall Z-0765-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Steris Corp
- Reason for recall
- A defective port adapter may affect the sterilization process of the attached endoscope.
- Action taken
- The firm contacted the consignees by letter and in person.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MED
- Quantity affected
- 40 units
- Distribution
- 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.
- Date initiated
- 2004-03-15
- Date posted
- 2004-07-20
- Date terminated
- 2004-05-18
- Location
- Mentor, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
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 |