FDA Medical Device Recalls (openFDA)
Steris Corp: 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
- Recall number
- Z-0765-04
- Recalling firm
- Steris Corp
- Product
- 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
- Status
- Terminated
- Initiated
- 2004-03-15
- Posted
- 2004-07-20
- Terminated
- 2004-05-18
- Reason
- A defective port adapter may affect the sterilization process of the attached endoscope.
- Root cause
- Process control
- Action
- The firm contacted the consignees by letter and in person.
- Quantity
- 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.
- Lot, serial or model codes
- Lots #2925196, #2911782, #2925238.
- 510(k) numbers
- ["K875280"]
- PMA numbers
- not on file
- Product code
- MED
- Firm FEI
- 1527821
- Firm city
- Mentor
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28