Medline procedure packs containing Shenli syringes — Class II medical device recall Z-2630-2024
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-2630-2024 |
|---|---|
| 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 | 21IMD970, 21KMA999, 23FBK320, 23GBU834, 23HBG572, 23IBE112, 23JBH284, 23KBE900, 23KBL354, 23LBL499, 23LBO850, 24CDB254, DYNDA2516B, DYNJ36932A, DYNJ58502C, DYNJ910121, PICCNC0028 |
Product
Medline procedure packs containing Shenli syringes, labeled as follows: 1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B ; 2) DIALYSIS PACK , Pack Number DYNJ36932A ; 3) DIALYSIS AV SHUNT #668229-V-LF, Pack Number DYNJ58502C ; 4) DIALYSIS ACCESS PACK, Pack Number DYNJ910121 ; 5) NO CATH DIALYSIS INSERTN TRAY , Pack Number PICCNC0028
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-2630-2024. 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.