Date Initiated by Firm | June 23, 2010 |
Date Posted | February 22, 2011 |
Recall Status1 |
Terminated 3 on March 14, 2012 |
Recall Number | Z-1393-2011 |
Recall Event ID |
56367 |
510(K)Number | K951295 |
Product Classification |
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories - Product Code KCT
|
Product | Tyvek Self-Seal Pouch with STERRAD Chemical Indicator 12332.
Intended to be used to contain medical devices that are being terminally sterilized in STERRAD Sterilization Systems. |
Code Information |
Lot Number: 2020 |
Recalling Firm/ Manufacturer |
Advanced Sterilization Products 33 Technology Drive Irvine CA 92618
|
For Additional Information Contact | 949-453-6400 |
Manufacturer Reason for Recall | The recall was initiated after Advanced Sterilization Products (ASP) discovered a non-conforming lot. The misaligned perforations may have caused the seal to be incomplete on some of the pouches, creating a potential breach for pouches being used to store sterilized equipment on shelves. |
FDA Determined Cause 2 | Process control |
Action | Advanced Sterilization Products (ASP) released Urgent: Product Recall notifications to its consignees identifying the affected product and explaining the reason for recall. The letter also discussed the impact of using this affected product and return instructions. The firm asked customers to examine their inventory, discontinue use of Tyvek Self-Seal Pouch with STERRAD Chemical Indicator 12332 and to return all unused affected products to Stericycle. Customers are to complete the Business Reply Card and return it to Stericycle. |
Quantity in Commerce | 470 |
Distribution | Worldwide Distribution -- USA, Argentina, Australia, Canada, Chile, Czech Republic, Hong Kong, India, Japan, Panama, Peru and Puerto Rico. |
Total Product Life Cycle | TPLC Device Report |
|
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.
|
510(K) Database | 510(K)s with Product Code = KCT
|