Date Initiated by Firm | June 19, 2012 |
Date Posted | September 07, 2012 |
Recall Status1 |
Terminated 3 on November 08, 2013 |
Recall Number | Z-2338-2012 |
Recall Event ID |
62925 |
510(K)Number | K042116 |
Product Classification |
Sterilizer, chemical - Product Code MLR
|
Product | STERRAD NX Cassette, Batch # 12A078.
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. |
Code Information |
Product Code: 10133 |
Recalling Firm/ Manufacturer |
Advanced Sterilization Products 33 Technology Dr Irvine CA 92618-2346
|
For Additional Information Contact | 949-453-6400 |
Manufacturer 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. |
FDA Determined Cause 2 | Error in labeling |
Action | Advanced Sterilization Products sent an "URGENT MEDICAL DEVICE RECALL (REMOVAL) letter dated July 16, 2012 to all their customers who purchased the STERRAD 100S and STERRAD NX System cassettes. The letter informed the customers of the problem identified and the actions to be taken. For the STERRAD NX System cassettes, there should be no impact to the functionality of these affected cassettes. Although printing may be smeared, illegible, or missing, the packaging has multiple references to the information, and the cassettes should be usable despite any printing error.
For the STERRAD 100S System cassettes, there is a chance that the barcode will be unreadable and the STERRAD 100S Sterilizer will not accept the cassette.
Customers were instructed to complete and return the business reply card and packing slip that are included in the letter. Customers were instructed to contact Stericycle at (888) 406-9303 for additional labels. Customers with questions about the recall letter were instructed to contact Stericycle at (888) 406-9303. |
Quantity in Commerce | 7,550 units |
Distribution | Nationwide Distribution. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = MLR
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