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U.S. Department of Health and Human Services

Class 3 Device Recall STERITITE Containers

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 Class 3 Recall
STERITITE Containers
see related information
Date Posted December 03, 2013
Recall Status1 Terminated on January 13, 2014
Recall Number Z-0434-2014
Recall Event ID 66502
Premarket Notification
510(K) Numbers
K023614  K030853  K080558 
Product Classification Wrap, Sterilization - Product Code FRG
Product STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902; STERITITE Mini Mid Size, 3" high, product code: 13903; STERITITE Container Kit, 1/2 size, 4" high, product code: 13904; STERITITE Container Kit, 3/4 size, 4" high, product code: 13905; STERITITE Container Kit, Full size, 4" high, product code: 13906. The ASP STERITITE sealed container system provides an efficient and cost-effective way to package and protect surgical instruments for sterilization, transportation, storage, and aseptic presentation of contents.
Code Information Batch numbers: Batch 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1071641 1071641 1030704 1030704 1071641 1030704 1071641 1071641 1071641 1071641 1030704 1030704 1071641 1071641 1071641 1079723 1079723 1079723 1079723 1079723 1079962 1079962 1079962 1079962 1079962 1079962 1079962 1079962 1079962 1079962 1079962 1079962 1081092 1081092 1081092 1081092 1081092 1081092 1081092 1081092 1081092 1081092 1081092 1071641 1081088 1081092 1081088 1081088 1081088 1081088 1081088 1081088 1081088 1081088 1081088 1081088 1081088 1082503 1081090 1081090 1081090 1081090 1082501 1082501 1082503 1082503 1082503 1082503 1082503 1082503 1082503 1082501 1082501 1082501 1082501 1082501 1082503 1082503 1082503 1081092 1082503 1081092 1081092 1081092 1081092 1081092 1081092 1081092 1085115 1081092 1081092 1081092 1086020 1086020 1086020 1086020 1086424 1086424 1081090 1086423 1087992 1086423 1082501 1081088 1085115 1085115 1086020 1081090 1087992 1086423 Batch 1030705 1030705 1030705 1030705 1030705 1030705 1030705 1071642 1071642 1071642 1071642 1071642 1071642 1071642 1071642 1071642 1030705 1030705 1030705 1030705 1030705 1030705 1078551 1078551 1078551 1078551 1078551 1078551 1078551 1078551 1078551 1079627 1079627 1079627 1079626 1079626 1079627 1079626 1079626 1079963 1079963 1079963 1080892 1079963 1080892 1080892 1080892 1080892 1080892 1080892 1080892 1080892 1080892 1080892 1079963 1080892 1079963 1079963 1079963 1079963 1079963 1079963 1079963 1079963 1080890 1079963 1080890 1080890 1080890 1080890 1081084 1081084 1081084 1080890 1080890 1081084 1081084 1080890 1080890 1080890 1081084 1081084 1081084 1081084 1081084 1081084 1081084 1082390 1081084 1082390 1082390 1081084 1082390 1084584 1084584 1084584 1085118 1085118 1085118 1082390 1082390 1082390 1082390 1085118 1082390 1082390 1082390 1081084 1082390 1081084 1085118 1086341 1081084 1081084 1085118 1086341 1081084 1081084 1081084 1081084 1081084 1081084 1085118 1085745 1085745 1085461 1085461 1085461 1085461 1084584 1085461 1084584 1084584 1084584 1084584 1084584 1084584 1085461 1085461 1084584 1085461 1085461 1085461 1085461 1085461 1085461 1085461 1087308 1087669 1088431 1085745 1084584 1086341 1084584 1087669 1087308 1085461 1088431 1084584 1085745 1085745 1087669 1087308 1085461 1088431 1084584 1087669 1087308 1085461 Batch 1030706 1030706 1030706 1030706 1030706 1030706 1030706 1030706 1030706 1030706 1030706 1030706 1030706 1071643 1030706 1030706 1030706 1030706 1030706 1071643 1071643 1071643 1071643 1071643 1030706 1071643 1071643 1071643 1071643 1071643 1071643 1071643 1071643 1071643 1071643 1071643 1079624 1079624 1079624 1079624 1030706 1030706 1079624 1079624 1081076 1081076 1081076 1081076 1081076 1081076 1081076 1081076 1079624 1081076 1081076 1081076 1081076 1081076 1081076 1081080 1071643 1081080 1071643 1081080 1071643 1081078 1081078 1081078 1081080 1082395 1081078 1081080 1081078 1081080 1081080 1082395 1081078 1081078 1081080 1082395 1081078 1081082 1085117 1085119 1081080 1082395 1081078 1085117 1081082 1085117 1085119 1081080 1085750 1082395 1085887 1081078 1085117 1085117 1085119 1081080 1085750 1082395 1082395 1085887 1085887 1085117 1085119 1085119 1082396 1081080 1085750 1082395 1085887 1081078 1085117 1085119 1085119 1088721 1082396 1081080 1085750 1082395 1081082 1085887 1085117 1081078 1081080 1081082 1085119 1085750 1085887 1085117 1081078 Batch 1030707 1030707 1030707 1030707 1030707 1030707 1030707 1030707 1030707 1071645 1071645 1071645 1071645 1071645 1071645 1071645 1071645 1071645 1071645 1071645 1071645 1071645 1071645 1071645 1030707 1071645 1030707 1071645 1071645 1030707 1078552 1078552 1078552 1078552 1078552 1078552 1078552 1078552 1078552 1078552 1078552 1078552 1078552 1078552 1030707 1078552 1078552 1078552 1078552 1078552 1078552 1078552 1078552 1078552 1078552 1078552 1078552 1078552 1078552 1078552 1078552 1078552 1078552 1078552 1078552 1078552 1078552 1078552 1078552 1078552 1078552 1078552 1078552 1078552 1078552 1078552 1078552 1078552 1081066 1078552 1081068 1081068 1081068 1081070 1081070 1081070 1081068 1081068 1081068 1081068 1081068 1081066 1081070 1081066 1081066 1081074 1081074 1081074 1081074 1081074 1081074 1081074 1081070 1081074 1081074 1081066 1081074 1081070 1081070 1081074 1081070 1081074 1081074 1081074 1081074 1081074 1081066 1081074 1082510 1082510 1082510 1082510 1082510 1082510 1081068 1082510 1082510 1081068 1081072 1082405 1081068 1081068 1082405 1082405 1082405 1082405 1082405 1082405 1082405 1081072 1081072 1081074 1081074 1081074 1081074 1082510 1082510 1082510 1082510 1088249 1088249 1081066 1088249 1088249 1082405 1088249 1088249 1088249 1088249 1088249 1082405 1082405 1082405 1082405 1082405 1081070 1081070 1081070 1081070 1082405 1081072 1081072 1087762 1081072 1087762 1087762 1087762 1081074 1085347 1087762 1081074 1089300 1081074 1088249 1089300 1088249 1088249 1081074 Batch 1030708 1030708 1030708 1030708 1070708 1030708 1070708 1030708 1070708 1030708 1030708 1030708 1030708 1030708 1030708 1030708 1030708 1030708 1030708 1030708 1030708 1030708 1071646 1071646 1071646 1071646 1071646 1071646 1076598 1076598 1076598 1076598 1071646 1071646 1076598 1071646 1076598 1076598 1076598 1076598 1076598 1076598 1076598 1076598 1076598 1076598 1076598 1078553 1078553 1076598 1076598 1078553 1078553 1078553 1078553 1078553 1078553 1076598 1078553 1078553 1076598 1076598 1076598 1078553 1076598 1078553 1078553 1078553 1078553 1078553 1078553 1078553 1030708 1076598 1078553 1078553 1078553 1078553 1078553 1078553 1078553 1078553 1078553 1078553 1078553 1081060 1081060 1081060 1081060 1081060 1081060 1081062 1081062 1081062 1081062 1081062 1081062 1081062 1081062 1081062 1081062 1081060 1081062 1081060 1081062 1081062 1078553 1081062 1081062 1081062 1081062 1078553 1078553 1078553 1078553 1078553 1081062 1078553 1078553 1078553 1078553 1081064 1081064 1081064 1081064 1081064 1078553 1078553 1081064 1081064 1078553 1078553 1078553 1078553 1081064 1078553 1081064 1081064 1081064 1078553 1081064 1081064 1081064 1082512 1082512 1081064 1082512 1081064 1078553 1081064 1082514 1082514 1082514 1082514 1082514 1082514 1082514 1082514 1078553 1082514 1082514 1078553 1082514 1078553 1082514 1081064 1082514 1081064 1081064 1084038 1084038 1084038 1084038 1084038 1084038 1084038 1084038 1082514 1084038 1082514 1084038 1082514 1084038 1084038 1084038 1084038 1084038 1084038 1084038 1082512 1082512 1082512 1084038 1084477 1084477 1084477 1081064 1084477 1084477 1084038 1081064 1081064 1085116 1081064 1085116 1085116 1084038 1085116 1085116 1085116 1085116 1085339 1085116 1085116 1085116 1084477 1085116 1084477 1081064 1081064 1084477 1081064 1085638 1081064 1081064 1081064 1084038 1084038 1084038 1084038 1084038 1084477 1084038 1085339 1086422 1085339 1085339 1085339 1085339 1085339 1085339 1085116 1085339 1085116 1085638 1085116 1085116 1085116 1085116 1085116 1084477 1085638 1084477 1084477 1086154 1084477 1084477 1086154 1086154 1086154 1086154 1086154 1086154 1086154 1087554 1086154 1087554 1087554 1087554 1087554 1087554 1087554 1086154 1086154 1086154 1087554 1087554 1087554 1087554 1087954 1087954 1087554 1087954 1084038 1084038 1084038 1084038 1088118 1085116 1088118 1088118 1088118 1084038 1085116 1085116 1085116 1085116 1085116 1087673 1085116 1087673 1087673 1087673 1087673 1087673 1087673 1087673 1085339 1085339 1085638 1085339 1085638 1085638 1086950 1086950 1086950 1086422 1087554 1087954 1088118 1087954 1088118 1086422 1087954 1087954 1087954 1087954 1091472 1089742 1089742 1090276 1090276 1090276 1090276 1090276 1090276 1087673 1087673 1087673 1087673 1087673 1088647 1088647 1089742 1092105 1090890 1088647 1086950 1087554 1088118 1089742 1090276 1091732 1092105 1088118 1088647 1090890 1087554 1087554 1088118 1087554 1087554 1087554 1087554 1087954 1087954 1088118 1088118 1088118 1088118 1088118 1086154
Recalling Firm/
Manufacturer
Advanced Sterilization Products
33 Technology Dr
Irvine, California 92618-2346
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: Device Design
Action 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).
Quantity in Commerce 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.
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 = FRG and Original Applicant = CASE MEDICAL, INC.
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