Reported Dec 11, 2013 · Terminated

STERITITE Containers

Advanced Sterilization Products

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Advanced Sterilization Products · 33 Technology Dr · Irvine, CA · 92618-2346

Is this the product you have?

STERITITE Containers

5 of 5 products

Products covered by this recall
Model / numberProduct as published
13902STERITITE Container Kit, 1/4 size, 3" high
13903STERITITE Mini Mid Size, 3" high
13904STERITITE Container Kit, 1/2 size, 4" high
13905STERITITE Container Kit, 3/4 size, 4" high
13906.STERITITE Container Kit, Full size, 4" high, 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.
Lot codes and dates
  • Batch numbersBatch

    132 of 132 codes

    • 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
    Batch

    169 of 169 codes

    • 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
    Batch

    133 of 133 codes

    • 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
    Batch

    188 of 188 codes

    • 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
    Batch

    372 of 372 codes

    • 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
Amount recalled
267 units total (252 units in US)

Where it was sold

  • Nationwide

Why it was recalled

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.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 13, 2014 · Data as of Sep 19, 5:25 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.