Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid…

Is this the product you have?

• Colonoscopefor endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve)
• Model Numbers
  • CF-2T160I
  • CF-2T160L
  • CF-H170I
  • CF-H170L
  • CF-H180AI
  • CF-H180AL
  • CF-H180DI
  • CF-H180DL
  • CF-H190I
  • CF-H190L
  • CF-HQ190I
  • CF-HQ190L
  • CF-LV1I
  • CF-LV1L
  • CF-Q150I
  • CF-Q150L
  • CF-Q160S
  • CF-Q180AI
  • CF-Q180AL. 510(k)
• Numbers
  • K954451
  • K112680
  • K100584
  • K051645
  • K111756
  • K001241
  • K911278

Lot codes and dates

• Model Number (UDI-DI)
  • CF-2T160I (04953170307645)
  • CF-2T160L (04953170307652)
  • CF-H170I (04953170334184)
  • CF-H170L (04953170334160)
  • CF-H180AI (04953170339585)
  • CF-H180AL (04953170339608)
  • CF-H180DI (04953170339639)
  • CF-H180DL (04953170339653)
  • CF-H190I (04953170305177)
  • CF-H190L (04953170305153)
  • CF-HQ190I (04953170305139)
  • CF-HQ190L (04953170305115)
  • CF-LV1I (04953170312410)
  • CF-LV1L (04953170312397)
  • CF-Q150I (04953170307621)
  • CF-Q150L (04953170307638)
  • CF-Q160S (04953170307669)
  • CF-Q180AI (04953170307690)
  • CF-Q180AL (04953170307706)

Amount recalled

3344 units

This recall covers 22 products

The agency filed one notice per product. You are reading one of them; the other 21 are below.

• Bronchoscope-for endoscopy and endoscopic surgery within the airways and…
• Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasound guided…
• Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.
• Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and…
• Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lumens and…
• Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for…
• Gastrointestinal videoscope-indicated for use within the upper digestive tract…
• Hysteroscope-For endoscopic diagnosis within the uterus
• Hysterovideoscope-For endoscopic diagnosis within the uterus
• Hysterofiberscope-For endoscopic diagnosis within the uterus.
• Tracheal fiberscope-airway management, which includes observation to access airway…
• Tracheal videoscope- For airway management, which includes observation to access airway…

9 more are in the archive.

Where it was sold

• Nationwide

Why it was recalled

Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

This product could cause temporary or reversible health problems — stop using it.