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U.S. Department of Health and Human Services

Class 2 Device Recall ASP Automatic Endoscope Reprocessor (AER)

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 Class 2 Device Recall ASP Automatic Endoscope Reprocessor (AER)see related information
Date Initiated by FirmFebruary 19, 2010
Date PostedDecember 16, 2010
Recall Status1 Terminated 3 on July 30, 2013
Recall NumberZ-0628-2011
Recall Event ID 57281
510(K)NumberK832458 
Product Classification Endoscope and/or accessories - Product Code KOG
ProductASP Automatic Endoscope Reprocessor (AER), Product Code: 20300 & 20301 The AER is a machine designed to automatically wash and high-level disinfect flexible, submersible fiberoptic or video endoscopes.
Code Information Product Code: 20300 & 20301
FEI Number 3003662624
Recalling Firm/
Manufacturer		 Advanced Sterilization Products
33 Technology Drive
Irvine CA 92618
For Additional Information ContactRuben Lawson
949-789-8545
Manufacturer Reason
for Recall		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
FDA Determined
Cause 2		Pending
ActionAdvanced Sterilization Products sent an URGENT: PRODUCT CORRECTION letter dated February 19, 2010, to all customers. The letter identified the product, the problem, and the action to be taken by the customer. The recall communication was initiated with ASP forwarding a "Urgent: Product Correction" letter with attached customer fax-back response form to the affected customers. Customers were also instructed to complete and sign the enclosed customer fax-back response form indicating that they have disconnected the heater on the ASP AER according to the instructions provided and fax the form to 1-888-345-1435. If customers have any questions or need assistance, they were instructed to call ASP Professional Services at 888-783-7723, option 3 then option 1.
Quantity in Commerce1,881 units (1514 in US)
DistributionWorldwide Distribution -- United States, Argentina Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, Hungary, Mexico, Panama, Guatemala, Honduras, Poland, Puerto Rico, Virgin Islands, Singapore, Taiwan, Venezuela, Croatia, and Bulgaria.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KOG
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