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

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0434-2014%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.