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U.S. Department of Health and Human Services

Class 2 Device Recall STERRAD 100NX

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 Class 2 Device Recall STERRAD 100NX see related information
Date Posted March 30, 2013
Recall Status1 Terminated on September 30, 2013
Recall Number Z-1026-2013
Recall Event ID 64692
510(K)Number K071385 
Product Classification Sterilizer, chemical - Product Code MLR
Product STERRAD 100NX Sterilization System, P/N 10104

Product Usage:
The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.
Code Information 395019
1353757
1326427
1373843
1360565
1388044
1343591
1354415
1397390
1396342
1396803
1399428
1401283
1402478
1400712
1397076
1397076
1402363
1396553
1402736
1373013
1405947
1406635
1406048
1407058
1392751
1353149
1403977
1407279
1374042
1374880
1405691
1397072
1406519
1402824
1406434
1407139
1407240
1407328
1407239
1407323
1413713
1413713
1412541
1412668
1412341
1396531
1407125
1397382
1395148
1416948
1407064
1405852
1406662
1407318
1407311
1418803
1418803
1420510
1407319
1374052
1405537
1399625
1399625
1399625
1399625
1422430
1419669
Recalling Firm/
Manufacturer
Advanced Sterilization Products
33 Technology Dr
Irvine CA 92618-2346
For Additional Information Contact
949-453-6400
Manufacturer Reason
for Recall
The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX and STERRAD 200 Sterilization Systems may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Advanced Sterilization Products sent an Urgent Medical Device Field Safety Notification letter dated March 22, 2013 to all customers. The letter identified the affected products, problem and actions to be taken. Customers are instructed to report any complaints or suspected problems with their STERRAD 100NX and/or STERRAD 200 System to ASP Professional Services directly at (888) 783-7723 and select option #2.
Quantity in Commerce 1500 units
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MLR and Original Applicant = ADVANCED STERILIZATION PRODUCTS
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