Recall Z-0281-2009 ยท FEB Accessories, Cleaning, For Endoscope
Advanced Sterilization Products
ASP Automatic Endoscope Reprocessor, AER Plus Product Code 20300 and AER with printer Product Code 20301 The AER is a machine designed to automatically wash and high-level disinfect flexible, submersible fiberoptic or video endoscopes.
| Date | Nov 7, 2008 (initiated Sep 11, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Component design/selection |
| Action | ASP is mailing customer notification CL-101367 and AD-52976-001 in an Urgent Product Correction envelope starting the week of September 8, 2008. The letter advises that the firm has received customer reports of residual high-level disinfectant solution remaining in endoscopes that have been reprocessed in the ASP Automatic Endoscope Reprocessor (AER). If high-level disinfectant, or other fluids, remain in the endoscope after reprocessing, contact with patient mucous membranes may occur and result in chemical burns, irritation (chemical colitis), or other symptoms. ASP has tested the PENTAX |
| Quantity | 1,578 units installed in the US and 367 units installed internationally |
| Distribution | Worldwide Distribution --- including USA and countries of Italy, UK, Uruguay, Argentina, Chile, Colombia, Ecuador, Puerto Rico, Mexico, Australia, China, Singapore, Taiwan, Middle East, Canada, Czech Republic, Portugal, South Africa, Spain, Hungary, Poland, Brazil, Russia, Egypt, and Slovenia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K832458 | AUTOMATIC ENDOSCOPE American Endoscopy, Inc., Oct 20, 1983 |