STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902; STERITITE Mini Mid Size, 3" high,

FDA device recall Z-0434-2014 · posted 2013-12-03 · Terminated

Recall details

Recalling firm

Advanced Sterilization Products

Reason for recall

Advanced Sterilization Products (ASP) is recalling the SteriTite containers because they do not have consistent data to show that sterility assurance level of 10(-6) is achieved during the half-cycle test runs on new, unprocessed containers.

Action taken

Advanced Sterilization Products (ASP) sent a Urgent Medical Device Field Safety Notification letter dated October 3, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers who received the SteriTite Containers. Customers were instructed to: Provide this notice to anyone in your facility that needs to be informed. Maintain a copy of this notice with the affected product. Maintain awareness of this notice. Customers are instructed to contact Stericycle at (888) 912-7092 for additional questions related to the recall letter. Customers are instructed to report any complaints or suspected problems related to the recall by contacting ASP at (888) STERRAD (888-783-7723).

Root cause

Device Design

Status

Terminated

Product code

FRG

Quantity affected

267 units total (252 units in US)

Distribution

Worldwide Distribution - USA (nationwide) and the countries of Australia, Vietnam, Thailand, Malaysia, China, Korea (South), Mexico, Spain, Singapore, Hong Kong and Portugal.

Date initiated

2013-10-03

Date posted

2013-12-03

Date terminated

2014-01-13

Location

Irvine, CA

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