Halyard IV Start Kit Non-Sterile REF: KRIV26-02 — Class II medical device recall Z-3109-2026
Ongoing recall by AVID Medical, Inc., reported 2026-09-16, distributed nationwide. Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which lacks sterility a
| Recall number | Z-3109-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | AVID Medical, Inc., Toano, VA, United States |
| Recall initiated | 2026-07-14 |
| Classified | 2026-09-04 |
| Reported by FDA | 2026-09-16 |
| Distributed | Nationwide (US) |
| Quantity | 98 kits |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 10809160460481 |
| Lot numbers | 1658438 |
| Model numbers | KRIV26-02 |
Product
Halyard IV Start Kit Non-Sterile REF: KRIV26-02
Reason for recall
Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which lacks sterility assurance due to to wrinkles in the paper lidding which may breach the seal area.
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-3109-2026. 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.