FEMORAL ARTERY PACK-LF — Class II medical device recall Z-1065-2023
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2023-02-15, distributed nationwide. Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the st
| Recall number | Z-1065-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2022-11-17 |
| Classified | 2023-02-06 |
| Reported by FDA | 2023-02-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA, JP, MX, PA |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10193489377941, 40193489377942 |
| Lot numbers | 22JME722, 22KMA163 |
| Model numbers | DYNJ0826625Q |
Product
FEMORAL ARTERY PACK-LF. Sterile Procedural Tray
Reason for recall
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
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-1065-2023. 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.