STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization System is a low temperature general purpose steri

FDA device recall Z-2174-2013 · posted 2013-09-10 · Terminated

Recall details

Recalling firm

Advanced Sterilization Products

Reason for recall

The recall of the STERRAD 100NX Cassettes was initiated because Advanced Sterilization Products (ASP) does not have adequate data to support the effectiveness of the packaging's leak indicator for the entire duration of the STERRAD 100 NX System cassette's 15 month shelf life.

Action taken

ASP sent an Urgent Medical Device Field Safety Notification letter dated July 25, 2013, to all affected customers. The recall letter informed the customers of the problem identified and the actions to be taken. Customers were instructed to contact Stericycle directly at (866) 562-5937 to report any complaints or suspected problems with their STERRAD 100NX System cassette. For questions regarding this recall call 949-453-6400.

Root cause

Under Investigation by firm

Status

Terminated

Product code

MLR

Quantity affected

1,923 units

Distribution

Worldwide Distribution - USA (nationwide) and internationally to RU, VE, KW, SA, HU, GB, IT, HK, IL, MX, ZA, PH, GR, AE, IN, CO, KR, AU, IN, ES, SG, MY, TH, TR, TW, SI, BE, PL, EC, CN, JP, PA, DE, VN,

Date initiated

2013-07-25

Date posted

2013-09-10

Date terminated

2013-11-27

Location

Irvine, CA

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