Recall Z-1312-2015— Advanced Sterilization Products
Class II · Terminated
Class II FDA medical device recall by Advanced Sterilization Products, initiated 2014-12-24, terminated 2015-09-04. It names one FDA 510(k) clearance: K141693. Product: Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425. Reason: Advanced Sterilization Products (ASP) is recalling the Tyvek Rolls with STERRAD Chemical Indicator because they were shipped to customers after its expiration date of May 18, 2013..
- Recalling firm
- Advanced Sterilization Products
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-12-24
- Terminated
- 2015-09-04
- Firm location
- Irvine, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425
Reason for recall
Advanced Sterilization Products (ASP) is recalling the Tyvek Rolls with STERRAD Chemical Indicator because they were shipped to customers after its expiration date of May 18, 2013.
Data sourced from openFDA. This site is unofficial and independent of the FDA.