Tyvek Pouch/Roll with STERRAD Chemical Indicator — Class II medical device recall Z-1312-2015
Terminated recall by Advanced Sterilization Products, reported 2015-04-01. Advanced Sterilization Products (ASP) is recalling the Tyvek Rolls with STERRAD Chemical Indicator because the
| Recall number | Z-1312-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advanced Sterilization Products, Irvine, CA, United States |
| Recall initiated | 2014-12-24 |
| Classified | 2015-03-23 |
| Reported by FDA | 2015-04-01 |
| Terminated | 2015-09-04 |
| Countries outside the US | PT, SA |
| Quantity | 2 units |
| Reason classes | chemical contamination |
| Lot numbers | 68965-1241 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1312-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.