Tyvek Self-Seal Pouch with STERRAD Chemical Indicator 12332. Intended to be used to contain medical devices that are bei
FDA device recall Z-1393-2011 · posted 2011-02-22 · Terminated
Recall details
- Recalling firm
- Advanced Sterilization Products
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KCT
- Quantity affected
- 470
- Distribution
- Worldwide Distribution -- USA, Argentina, Australia, Canada, Chile, Czech Republic, Hong Kong, India, Japan, Panama, Peru and Puerto Rico.
- Date initiated
- 2010-06-23
- Date posted
- 2011-02-22
- Date terminated
- 2012-03-14
- Location
- Irvine, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STERRAD STERILIZATION POUCH (K951295) | Advanced Sterilization Products | 1995-05-19 |