FDA Device recall Z-1891-2026
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTERIOGRAM TRAY 00-402001T, 00-402001U CATH LAB-VEI…
- FDA Device
- Class II
- ongoing
- Published 2026-04-29
On 2026-04-29 the FDA classified a Class II recall of Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTERIOGRAM TRAY 00-402001T, 00-402001U CATH LAB-VEI… by Medline Industries, citing unapproved design changes to the products outside of the 510(k) clearance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1891-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-02-27 |
| Published | 2026-04-29 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Medline Industries |
| Distribution | US |
Product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTERIOGRAM TRAY 00-402001T, 00-402001U CATH LAB-VEIN PROCEDURES DYNJ60329A CENTRAL VENOUS ACCESS PACK-LF CVI5070 FISTULAGRAM PACK DYNJ66259 INVASIVE LINE INSERTION DYNJ44123C NON VASCULAR PACK DYNJ68037B, DYNJ68037C PICC ABSCESS PACK-LF DYNJ0774005G PICC LINEPACK (PCLUI)642-LF DYNJ47717B PICC PHC DYNJ37484C
Reason
Unapproved design changes to the products outside of the 510(k) clearance.
Identifiers
| code_info | 00-402001T UDI-DI 10193489939682 (EA) 40193489939683 (CS) LOTS 23EBT729 23GBR995 23GBS336 00-402001U UDI-D…00-402001T UDI-DI 10193489939682 (EA) 40193489939683 (CS) LOTS 23EBT729 23GBR995 23GBS336 00-402001U UDI-DI 10195327517380 (EA) 40195327517381 (CS) LOTS 23JBU819 23LBG449 24ABS585 24CBF190 24DBA960 24EBB048 24FBN231 24HBA892 24IBD316 24IBS824 DYNJ60329A UDI-DI 10193489972221 (EA) 40193489972222 (CS) LOT 24ABP714 CVI5070 UDI-DI 10195327526061 (EA) 40195327526062 (CS) LOT 24FBF359 DYNJ66259 UDI-DI 10193489325485 (EA) 40193489325486 (CS) LOT 22FMB867 DYNJ44123C UDI-DI 10195327599140 (EA) 40195327599141 (CS) LOTS 24ABQ097 24DMH637 24FMG692 24GMA523 24HME792 24JMA878 24JMI393 DYNJ68037B UDI-DI 10195327476458 (EA) 40195327476459 (CS) LOT 24HBK116 DYNJ68037C UDI-DI 10198459239328 (EA) 40198459239329 (CS) LOT 25BBO522 25DBR880 DYNJ0774005G UDI-DI 10193489271485 (EA) 40193489271486 (CS) LOTS 23DMC237 23EMC431 23FMG987 23HBL979 23JBG840 23KBJ401 23LBR858 24CBB784 24EBA7 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1891-2026%22
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