Recall Z-2337-2012— Advanced Sterilization Products

Name: FDA recall Z-2337-2012
Creator: U.S. Food and Drug Administration
Published: 2012-06-19

Class III · Terminated

Class III FDA medical device recall by Advanced Sterilization Products, initiated 2012-06-19, terminated 2013-11-08. It names one FDA 510(k) clearance: K991999. Product: STERRAD 100S Cassette, Batch # 12A077. The STERRAD 100S and STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form as a separate accessory. The STERRAD Cassettes are used in conjunction with the STERRAD Sterilizers, and each cassette model is for use only in the matching sterilizer model.. Reason: Advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX System cassettes because the camera used to verify printing on the Sterrad System cassettes was inadvertently disabled. The STERRAD 100S and STERRAD NX System cases were shipped without verification of proper printing..

Recalling firm: Advanced Sterilization Products
Classification: Class III
Status: Terminated
Initiated: 2012-06-19
Terminated: 2013-11-08
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K991999 — STERRAD 100S STERILIZERAdvanced Sterilization Products·cleared 2000-06-15

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

STERRAD 100S Cassette, Batch # 12A077. The STERRAD 100S and STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form as a separate accessory. The STERRAD Cassettes are used in conjunction with the STERRAD Sterilizers, and each cassette model is for use only in the matching sterilizer model.

Reason for recall

Advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX System cassettes because the camera used to verify printing on the Sterrad System cassettes was inadvertently disabled. The STERRAD 100S and STERRAD NX System cases were shipped without verification of proper printing.

Data sourced from openFDA. This site is unofficial and independent of the FDA.