ASP Automatic Endoscope Reprocessor (AER), Product Code: 20300 & 20301 The AER is a machine designed to automatically wa

FDA device recall Z-0628-2011 · posted 2010-12-16 · Terminated

Recall details

Recalling firm

Advanced Sterilization Products

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

Action taken

Advanced 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.

Root cause

Pending

Status

Terminated

Product code

KOG

Quantity affected

1,881 units (1514 in US)

Distribution

Worldwide Distribution -- United States, Argentina Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, Hungary, Mexico, Panama, Guatemala, Honduras, Poland, Puerto Rico, Virgin Islands, Singapore, T

Date initiated

2010-02-19

Date posted

2010-12-16

Date terminated

2013-07-30

Location

Irvine, CA

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