FDA Device recall Z-1438-2025
Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ80088
- FDA Device
- Class II
- ongoing
- Published 2025-04-02
On 2025-04-02 the FDA classified a Class II recall of Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ80088 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 ma….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1438-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-11 |
| Published | 2025-04-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ80088; 2) AV FISTULA PACK-LF, Pack Number DYNJ0131782J; 3) CABG, Pack Number DYNJ906462B; 4) CABG ACCESSORY PACK-LF, Pack Number DYNJ0261346U; 5) CARDIAC CATH PACEMAKER-LF, Pack Number DYNJ42997C; 6) CARDIAC CATH PACK, Pack Number DYNJ61256A; 7) CARDIAC CATH PACK-LF, Pack Number DYNJ61527; 8) CARDIAC CATH PACK-LF, Pack Number DYNJ53642C; 9) CARDIOVASCULAR PACK LJ-LF, Pack Number DYNJ49635F; 10) CAROTID PACK, Pack Number DYNJ0810062AI; 11) CASTRO CABG-COMPONENT PACK, Pack Number DYNJ44857T; 12) CATH PACK, Pack Number DYNJ59830A; 13) CHOG CARDIAC CATH PACK, Pack Number SYNJ10304B; 14) CICC, Pack Number DYNJ53854A; 15) CMHP PACEMAKER PACK, Pack Number DYNJ30217G; 16) DR NACKMAN VEIN PACK, Pack Number DYNJ56235; 17) ENDOVASCULAR AAA PACK-LF, Pack Number DYNJ55482F; 18) EP DEVICE, Pack Number DYNJ65916B; 19) EP STUDY PACK-LF, Pack Number DYNJ38059A; 20) FHZ PACEMAKER PACK, Pack Number DYNJ36931D; 21) GV OPEN HEART PACK, Pack Number DYNJ60618C; 22) HEART CABG CDS, Pack Number CDS983376Q; 23) HEART DRAPE & SUPPLY PACK, Pack Number DYNJ65226; 24) HH ARTERIOGRAM PACK, Pack Number DYNJ59466A; 25) LEX OPEN HEART, Pack Number DYNJ900968I; 26) MAJOR VASCULAR PACK SAFETY, Pack Number DYNJ54738C; 27) NIR PACK, Pack Number DYNJ63892A; 28) OPEN HEART, Pack Number DYNJ904261B; 29) OPEN HEART, Pack Number DYNJ904261B; 30) OPEN HEART, Pack Number DYNJ905021J; 31) OPEN HEART A PACK, Pack Number DYNJ04478R; 32) OPEN HEART ACC, Pack Number DYNJ23533D; 33) OPEN HEART CDS, Pack Number CDS840171AB; 34) OPEN HEART DRAPE PACK-LF, Pack Number DYNJ0382048N; 35) OPEN HEART PACK, Pack Number DYNJ45122C; 36) OPEN HEART PACK, Pack Number DYNJ55648; 37) OPEN HEART PACK, Pack Number DYNJ04381J; 38) OPEN HEART PACK & BASIN SET-LF, Pack Number DYNJ24300M; 39) OPEN HEART PACK-LF, Pack Number DYNJ0369758N; 40) OPEN HEART PART B PACK, Pack Number DYNJ43038N; 41) OPEN HEART SUPPLY, Pack Number DYNJ65641; 42) OPEN PACK, Pack Number DYNJ67442B; 43) PACEMAKER, Pack Number DYNJ59399I; 44) PACEMAKER IMPLANT PACK-LF, Pack Number DYNJ0373237M; 45) PACEMAKER PACK, Pack Number DYNJ66165; 46) PACEMAKER PACK, Pack Number DYNJ41134B; 47) PACEMAKER PACK, Pack Number DYNJ61260A; 48) PACEMAKER PACK, Pack Number DYNJ60635; 49) PACEMAKER PACK, Pack Number DYNJ42602C; 50) PACEMAKER PACK 0121271-LF, Pack Number DYNJ32897J; 51) PACEMAKER PACK CV-LF, Pack Number DYNJ39912B; 52) PACEMAKER PACK-LF, Pack Number DYNJ53112B; 53) PACEMAKER PACK-LF, Pack Number DYNJ51844B; 54) PACEMAKER PACK-LF, Pack Number DYNJ0854874R; 55) PEDI EP PACK, Pack Number DYNJ54750G; 56) PERMANENT PACING PACK-LF, Pack Number DYNJ22036F; 57) PK, OPEN HEART, Pack Number DYNJ44015B; 58) PK, OPEN HEART-CABG, Pack Number DYNJ45048C; 59) RR-ADULT PUMP PACK-LF, Pack Number DYNJ0394805N; 60) RRMC CAROTID PACK-2, Pack Number DYNJ33544L; 61) RR-PEDIATRIC PUMP PACK-LF, Pack Number DYNJ0394730P; 62) TAVR PACK, Pack Number DYNJ58386A; 63) THORACIC PACK, Pack Number DYNJ80309; 64) VASCULAR, Pack Number DYNJ45376G; 65) VASCULAR PACK, Pack Number DYNJ48288C; 66) VASCULAR PACK, Pack Number DYNJ54979; 67) VASCULAR PACK, Pack Number DYNJ64883C; 68) VASCULAR PACK, Pack Number DYNJ43945I; 69) VASCULAR PACK, Pack Number DYNJ43945I; 70) VASCULAR PACK, Pack Number DYNJ67426A; 71) VASCULAR PACK WRO-LF, Pack Number DYNJ41863C; 72) VASCULAR SUB, Pack Number DYNJ60681A; 73) VASCULAR SUB, Pack Number DYNJ60681A
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 | 1) Pack Number DYNJ80088: UDI/DI 10195327010522 (each) 40195327010523 (case), Lot Number 23DBG477A; 2) Pack Number DY…1) Pack Number DYNJ80088: UDI/DI 10195327010522 (each) 40195327010523 (case), Lot Number 23DBG477A; 2) Pack Number DYNJ0131782J: UDI/DI 10195327467548 (each) 40195327467549 (case), Lot Number 23LMD975A; 3) Pack Number DYNJ906462B: UDI/DI 10195327057886 (each) 40195327057887 (case), Lot Number 22GBV822Z; 4) Pack Number DYNJ0261346U: UDI/DI 10195327055967 (each) 40195327055968 (case), Lot Number 22GMB113A; 5) Pack Number DYNJ42997C: UDI/DI 10193489988420 (each) 40193489988421 (case), Lot Number 21JMG551A; 6) Pack Number DYNJ61256A: UDI/DI 10193489694918 (each) 40193489694919 (case), Lot Number 23JBH403A; 7) Pack Number DYNJ61527: UDI/DI 10193489578881 (each) 40193489578882 (case), Lot Number 21LBJ158A; 8) Pack Number DYNJ53642C: UDI/DI 10193489721607 (each) 40193489721608 (case), Lot Number 24AMF039A; 9) Pack Number DYNJ49635F: UDI/DI 10195327191405 (each) 40195327191406 (case), Lot Number 23LMF122A; 10) Pack Number DYNJ0810062AI: UDI/DI 10193489866049 (each) 401934898 |
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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-1438-2025%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.