FDA Device recall Z-3037-2024
Medline Convenience kits labeled as: 1) EP DRAPE PACK-LF, Pack Number DYNJ0209716K
- FDA Device
- Class II
- ongoing
- Published 2024-09-18
On 2024-09-18 the FDA classified a Class II recall of Medline Convenience kits labeled as: 1) EP DRAPE PACK-LF, Pack Number DYNJ0209716K 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-3037-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-08 |
| Published | 2024-09-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | n/a |
Product
Medline Convenience kits labeled as: 1) EP DRAPE PACK-LF, Pack Number DYNJ0209716K ; 2) MERCY COMBINED PACK-LF, Pack Number DYNJ0233004D ; 3) E P DRAPE PACK-LF , Pack Number DYNJ0373061J ; 4) PACEMAKER DRAPE PACK-LF , Pack Number DYNJ0406118K ; 5) FEMORAL ANGIOGRAPHY PACK, Pack Number DYNJ0618509F ; 6) EP DRAPE PACK-LF, Pack Number DYNJ22911I ; 7) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ36314J ; 8) SPLIT DRAPE , Pack Number DYNJ37265F ; 9) 4 DRAPE PROCEDURE PACK, Pack Number DYNJ39689D ; 10) DR MOTT DRAPE PACK, Pack Number DYNJ42065B ; 11) PK, EP LAB, Pack Number DYNJ43815C ; 12) MAYO STAND PACK , Pack Number DYNJ50738; 13) DAA BI-LAT, Pack Number DYNJ903538C; 14) PACEMAKER , Pack Number DYNJ903545C; 15) CSTM NEONATAL FEM DRAPE PK, Pack Number DYNJCD0114
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 | DYNJ0209716K , Lot Number 19ABR348 ; DYNJ0209716K , Lot Number 19CBC954 ; DYNJ0209716K , Lot Number 19CBY010 ; DYNJ0…DYNJ0209716K , Lot Number 19ABR348 ; DYNJ0209716K , Lot Number 19CBC954 ; DYNJ0209716K , Lot Number 19CBY010 ; DYNJ0209716K , Lot Number 19PBC426 ; DYNJ0233004D , Lot Number 19BKC696 ; DYNJ0233004D , Lot Number 19EKB353 ; DYNJ0233004D , Lot Number 19EKD788 ; DYNJ0233004D , Lot Number 19IKB771 ; DYNJ0233004D , Lot Number 19JKB511 ; DYNJ0233004D , Lot Number 20AKC285 ; DYNJ0233004D , Lot Number 20CKA142 ; DYNJ0233004D , Lot Number 20EKA118 ; DYNJ0233004D , Lot Number 20EKB817 ; DYNJ0233004D , Lot Number 20FKA173 ; DYNJ0233004D , Lot Number 20HKC130 ; DYNJ0233004D , Lot Number 20LKA046 ; DYNJ0373061J , Lot Number 21IBN110 ; DYNJ0373061J , Lot Number 21IBN112 ; DYNJ0373061J , Lot Number 21IBW039 ; DYNJ0373061J , Lot Number 21JBQ249 ; DYNJ0373061J , Lot Number 21JBQ254 ; DYNJ0373061J , Lot Number 22CBE209 ; DYNJ0373061J , Lot Number 22DBD601 ; DYNJ0373061J , Lot Number 22DBE605 ; DYNJ0373061J , Lot Number 22JBF498 ; DYNJ0373061J , Lot Number 22KBK232 ; DYNJ0373061J |
|---|
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-3037-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.