Automatic Endoscope

• • Terminated Z-0628-2011 FDA Unclassified (pre-2012) ·initiated 19 Feb 2010 ·on shared 510(k) K832458

  The recall was initiated because Advanced Sterilization Products (ASP) received three customer reports of elevated temperature of the high-level disinfectant solution used in the ASP AER as a result of a possible temperature monitoring system malfunction. This recall communication advised consignees that if high-level disinfectants are exposed to elevated temperatures, fumes may occur and resul

• • Terminated Z-0281-2009 FDA Unclassified (pre-2012) ·initiated 11 Sep 2008 ·on shared 510(k) K832458

  Residual high-level disinfectant solution remaining in endoscopes that have been reprocessed in the ASP Automatic Endoscope Reprocessor. If high-level disinfectant, or other fluids, remains in the endoscope after reprocessing, contact with the mucous membranes may occur and result in chemical burns, irritation (chemical colitis), or other symptoms.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K832458 ↗

FDA Product Code

NVE

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Retrieval Forceps

  Class II

  FDA 510(k) K820239 Active Cleared 26 Mar 1982

• Percutaneous Endoscopic Gastroscopy

  Class II

  FDA 510(k) K833492 Active Cleared 29 Nov 1983

• Proxima 1 Ph Monitor

  Class I

  FDA 510(k) K841384 Active Cleared 19 Jul 1984

• Papillotomes

  Class II

  FDA 510(k) K820240 Active Cleared 26 Mar 1982

• Lavaging Catheters

  Class II

  FDA 510(k) K822061 Active Cleared 20 Jul 1982

• Pigtail Stents

  Class II

  FDA 510(k) K821819 Active Cleared 20 Aug 1982

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