FDA Device recall Z-2630-2024
Medline procedure packs containing Shenli syringes, labeled as follows: 1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B
- FDA Device
- Class II
- ongoing
- Published 2024-09-04
On 2024-09-04 the FDA classified a Class II recall of Medline procedure packs containing Shenli syringes, labeled as follows: 1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B by Medline Industries Northfield, citing 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 m….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2630-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-08 |
| Published | 2024-09-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | n/a |
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
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.
Identifiers
| code_info | DYNDA2516B , Lot Number 23IBE112 ; DYNDA2516B , Lot Number 23JBH284 ; DYNDA2516B , Lot Number 23KBE900 ; DYNDA2516B…DYNDA2516B , Lot Number 23IBE112 ; DYNDA2516B , Lot Number 23JBH284 ; DYNDA2516B , Lot Number 23KBE900 ; DYNDA2516B , Lot Number 23LBO850 ; DYNJ36932A , Lot Number 23FBK320 ; DYNJ36932A , Lot Number 23GBU834 ; DYNJ36932A , Lot Number 23HBG572 ; DYNJ36932A , Lot Number 23LBL499 ; DYNJ58502C , Lot Number 21IMD970 ; DYNJ58502C , Lot Number 21KMA999 ; DYNJ910121 , Lot Number 24CDB254 ; PICCNC0028 , Lot Number 23KBL354 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2630-2024%22
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