Medline procedure packs containing Shenli syringes — Class II medical device recall Z-2632-2024
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-09-04. Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. L
| Recall number | Z-2632-2024 |
|---|---|
| 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 | 2024-04-08 |
| Classified | 2024-08-28 |
| Reported by FDA | 2024-09-04 |
| Quantity | 1,679,067 units |
| Reason classes | packaging, device malfunction |
| Lot numbers | 2019021190, 2019091850, 2019120950, 2021052850, 2021062250, 2021071950, 2021092150, 2022012850, 2023010390, 2023031590, 2023112190, ECVC3260, ECVC7440, ECVC7445, ECVC7445A, ECVC8045, ECVC8105 |
| Model numbers | DYNDA1431A, ECVC3260, ECVC7440, ECVC7445, ECVC7445A, ECVC8045, ECVC8105 |
Product
Medline procedure packs containing Shenli syringes, labeled as follows: 1) NEURO ANGIO PACK, Part Number DYNDA1431A; 2) CVC INSERT BUNDLE 16CM, Part Number ECVC3260; 3) CENTRAL LINE INSERTION KIT, Part Number ECVC7440; 4) CENTRAL LINE INSERTION KIT, Part Number ECVC7445; 5) CENTRAL LINE INSERTION KIT W/20CM CATH, Part Number ECVC7445A; 6) VANTEX 7FR 3L 20CM CVC BUNDLE US, Part Number ECVC8045; 7) CVC DOUBLE LUMEN 16CM, Part Number ECVC8105
Reason for recall
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
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-2632-2024. 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.