Recall Z-0434-2014— Advanced Sterilization Products
Class III · Terminated
Class III FDA medical device recall by Advanced Sterilization Products, initiated 2013-10-03, terminated 2014-01-13. It names 3 FDA 510(k) clearances: K080558, K023614, K030853. 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..
- Recalling firm
- Advanced Sterilization Products
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2013-10-03
- Terminated
- 2014-01-13
- Firm location
- Irvine, CA, United States
510(k) clearances named in this recall
3 on FDA's record- K080558 — STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS
- K023614 — STERITITE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM
- K030853 — STERITITE PERFORATED BASE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02-POLYPROPYLENE NON-WOVEN DISPOSABLE FI
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.