- Relieva Flex Sinus Guide Catheter — Class II medical device recall Z-1639-2013
Terminated recall by Surgical Instrument Service And Savings, Inc., reported 2013-07-10, distributed nationwide. The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point whe
| Recall number | Z-1639-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Surgical Instrument Service And Savings, Inc., Redmond, OR, United States |
| Recall initiated | 2013-05-03 |
| Classified | 2013-07-01 |
| Reported by FDA | 2013-07-10 |
| Terminated | 2013-07-11 |
| Distributed | Nationwide (US) |
| Quantity | 4 |
| Reason classes | sterility, packaging |
| Lot numbers | 122429 |
| Model numbers | GC070RF, SIS100B |
Product
- Relieva Flex Sinus Guide Catheter (Green) Tip Shape: F-70 Ref. GC070RF Lot 122429 - Relieva Luma Sentry 20 Tip Angle, 0.035 Diameter 100cm Ref. SIS100B Lot 122429 Manual surgical instrument for general use
Reason for recall
The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
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-1639-2013. 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.