FDA Device recall Z-0434-2014
STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902
- FDA Device
- Class III
- terminated
- Published 2013-12-11
On 2013-12-11 the FDA classified a Class III recall of STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902 by Advanced Sterilization Products, citing 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 d….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0434-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-10-03 |
| Published | 2013-12-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Advanced Sterilization Products |
| Distribution | US |
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.
Reason
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.
Identifiers
| code_info | Batch numbers: Batch 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030704 1030…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 1 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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FDA Device · Class II · 2015-08-19 · Advanced Sterilization Products
All Advanced Sterilization Products recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0434-2014%22
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