Medline Convenience kits labeled as: 1) ECMO INSERTION BUNDLE W/O… — Class II medical device recall Z-3021-2024
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-09-18. Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. L
| Recall number | Z-3021-2024 |
|---|---|
| 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 | 2024-09-06 |
| Reported by FDA | 2024-09-18 |
| Reason classes | packaging, device malfunction |
| Lot numbers | 18LBQ229, 19ABD460, 19ABJ657, 19BBC131, 19BBI698, 19BKC672, 19CBB947, 19CBO914, 19DBC698, 19DBO702, 19DBQ381, 19EBB616, 19FBD994, 19GBA816, 19HBB067, 19IBB771, 19IBE072, 19IBK685, 19JBE636, 19JDB044, 19KBC727, 19KBF911, 19KBJ696, 19KBO216, 19KBP348, 19LBT637, 19LBU531, 19RBC166, 19SBB262, 19VBB656, 2019012590, 2022022450, 2022030150, 2022061090, 2022103180, 20ABM496, 20ABR888, 20BBK386, 20CBC820, 20CBL632 and 101 more |
Product
Medline Convenience kits labeled as: 1) ECMO INSERTION BUNDLE W/O CANNULA, Pack Number CVI4915; 2) PORT ACCESS TRAY, Pack Number DYNDC1318D; 3) KNEE ARTHROSCOPY PACK-LF, Pack Number DYNJ0101308C ; 4) UNIVERSAL PLASTIC , Pack Number DYNJ04047C ; 5) JAM CATH LAB MINOR PACK , Pack Number DYNJ17507B ; 6) STARTER PACK CMH-LF , Pack Number DYNJ41737C ; 7) DELIVERY PACK ME-LF , Pack Number DYNJ45589B ; 8) STERILE STARTER SET PACK, Pack Number DYNJ47814; 9) IVF PACK, Pack Number DYNJ63783; 10) VI PACK , Pack Number DYNJ64811; 11) VI PACK , Pack Number DYNJ64871; 12) IR CENTRAL KIT, Pack Number DYNJ68285; 13) PICC KIT 4F SL PL MAX BARRIER, Pack Number PICC0011; 14) PICC KIT 4F SL PL MAX BARRIER, Pack Number PICC0012; 15) LACERATION TRAY, Pack Number SUT20955; 16) UMBILICAL VESSEL TRAY, Pack Number UVT1100A; 17) UMBILICAL INSERTION W/3.5 CATH, Pack Number UVT1225; 18) UMBILICAL INSERTION W/3.5 CATH, Pack Number UVT1225H ; 19) UMBILICAL TRAY W/3.5&5FR CATH , Pack Number UVT1250H
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-3021-2024. 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.