--- title: "Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ80088;... — FDA record Z-1438-2025 | Is It on Recall" description: "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" url: https://isitonrecall.com/recall/fda-device-z-1438-2025-medline-procedure-kits-labeled-as-1-av-fistula-pack-pack-number-dynj80088-2-av-fistula-pack-lf-pack/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ80088; 2) AV FISTULA PACK-LF, Pack Number DYNJ... — FDA record Z-1438-2025 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Feb 11, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **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; ... - **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. - **Classification**: Class II - **Recalling firm**: MEDLINE INDUSTRIES, LP - Northfield - **Quantity**: 3860 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-1438-2025 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1438-2025%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | 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) 40193489866040 (case), Lot Number 22CMB582A; 11) Pack Number DYNJ44857T: UDI/DI 10195327221959 (each) 40195327221950 (case), Lot Number 22JBD481Z; 12) Pack Number DYNJ59830A: UDI/DI 10193489570236 (each) 40193489570237 (case), Lot Number 21EMF434A; 13) Pack Number SYNJ10304B: UDI/DI 10193489786965 (each) 40193489786966 (case), Lot Number 21LBD584A; 14) Pack Number DYNJ53854A: UDI/DI 10193489631517 (each) 40193489631518 (case), Lot Number 21GMB561A; 15) Pack Number DYNJ30217G: UDI/DI 10193489922141 (each) 40193489922142 (case), Lot Number 23CBN679A; 16) Pack Number DYNJ56235: UDI/DI 10889942621552 (each) 40889942621553 (case), Lot Number 23EBD843A; 17) Pack Number DYNJ55482F: UDI/DI 10195327332273 (each) 40195327332274 (case), Lot Number 23BBS877A; 18) Pack Number DYNJ65916B: UDI/DI 10193489902044 (each) 40193489902045 (case), Lot Number 23JBT190A; 19) Pack Number DYNJ38059A: UDI/DI 10193489401110 (each) 40193489401111 (case), Lot Number 20LMF803A; 20) Pack Number DYNJ36931D: UDI/DI 10193489927559 (each) 40193489927550 (case), Lot Number 23BBS364Z; 21) Pack Number DYNJ60618C: UDI/DI 10193489475630 (each) 40193489475631 (case), Lot Number 22GMD148Z; 22) Pack Number CDS983376Q: UDI/DI 10195327379797 (each) 40195327379798 (case), Lot Number 23IBG370Z; 23) Pack Number DYNJ65226: UDI/DI 10193489253672 (each) 40193489253673 (case), Lot Number 20BDA909A; 24) Pack Number DYNJ59466A: UDI/DI 10193489562613 (each) 40193489562614 (case), Lot Number 21BBF996A; 25) Pack Number DYNJ900968I: UDI/DI 10193489453188 (each) 40193489453189 (case), Lot Number 22IBM300N; 26) Pack Number DYNJ54738C: UDI/DI 10193489778755 (each) 40193489778756 (case), Lot Number 21EBF317A; 27) Pack Number DYNJ63892A: UDI/DI 10195327176518 (each) 40195327176519 (case), Lot Number 23LME320A; 28) Pack Number DYNJ904261B: UDI/DI 10193489479539 (each) 40193489479530 (case), Lot Number 22IBN057Z; 29) Pack Number DYNJ904261B: UDI/DI 10193489479539 (each) 40193489479530 (case), Lot Number 22JBJ452Z; 30) Pack Number DYNJ905021J: UDI/DI 10195327281625 (each) 40195327281626 (case), Lot Number 23DBI088Z; 31) Pack Number DYNJ04478R: UDI/DI 10888277748835 (each) 40888277748836 (case), Lot Number 22GMA554A; 32) Pack Number DYNJ23533D: UDI/DI 10193489470659 (each) 40193489470650 (case), Lot Number 22GMC009A; 33) Pack Number CDS840171AB: UDI/DI 10195327167042 (each) 40195327167043 (case), Lot Number 22GMG011Z; 34) Pack Number DYNJ0382048N: UDI/DI 10195327537364 (each) 40195327537365 (case), Lot Number 23JBV598A; 35) Pack Number DYNJ45122C: UDI/DI 10193489496369 (each) 40193489496360 (case), Lot Number 21EME856A; 36) Pack Number DYNJ55648: UDI/DI 10889942581900 (each) 40889942581901 (case), Lot Number 21LBN735A; 37) Pack Number DYNJ04381J: UDI/DI 10888277745155 (each) 40888277745156 (case), Lot Number 23GMB245A; 38) Pack Number DYNJ24300M: UDI/DI 10193489823608 (each) 40193489823609 (case), Lot Number 23FBL428A; 39) Pack Number DYNJ0369758N: UDI/DI 10193489501247 (each) 40193489501248 (case), Lot Number 22GBO541Z; 40) Pack Number DYNJ43038N: UDI/DI 10195327263911 (each) 40195327263912 (case), Lot Number 23EMD464A; 41) Pack Number DYNJ65641: UDI/DI 10193489282986 (each) 40193489282987 (case), Lot Number 21BBF660A; 42) Pack Number DYNJ67442B: UDI/DI 10195327133542 (each) 40195327133543 (case), Lot Number 23DBR515A; 43) Pack Number DYNJ59399I: UDI/DI 10195327442071 (each) 40195327442072 (case), Lot Number 23HMB191A; 44) Pack Number DYNJ0373237M: UDI/DI 10193489369014 (each) 40193489369015 (case), Lot Number 23LBU493Z; 45) Pack Number DYNJ66165: UDI/DI 10193489319729 (each) 40193489319720 (case), Lot Number 20DBP548A; 46) Pack Number DYNJ41134B: UDI/DI 10889942011643 (each) 40889942011644 (case), Lot Number 21BBI489A; 47) Pack Number DYNJ61260A: UDI/DI 10193489857481 (each) 40193489857482 (case), Lot Number 21HMF542A; 48) Pack Number DYNJ60635: UDI/DI 10193489518153 (each) 40193489518154 (case), Lot Number 21IMG997A; 49) Pack Number DYNJ42602C: UDI/DI 10195327019198 (each) 40195327019199 (case), Lot Number 23BBR329A; 50) Pack Number DYNJ32897J: UDI/DI 10193489648102 (each) 40193489648103 (case), Lot Number 20AKB914A; 51) Pack Number DYNJ39912B: UDI/DI 10889942705078 (each) 40889942705079 (case), Lot Number 21GMA579A; 52) Pack Number DYNJ53112B: UDI/DI 10193489650617 (each) 40193489650618 (case), Lot Number 21IMF023A; 53) Pack Number DYNJ51844B: UDI/DI 10889942615773 (each) 40889942615774 (case), Lot Number 21LME446A; 54) Pack Number DYNJ0854874R: UDI/DI 10195327094966 (each) 40195327094967 (case), Lot Number 22CMB704A; 55) Pack Number DYNJ54750G: UDI/DI 10195327021351 (each) 40195327021352 (case), Lot Number 22GBH035A; 56) Pack Number DYNJ22036F: UDI/DI 10889942528899 (each) 40889942528890 (case), Lot Number 20FBH674A; 57) Pack Number DYNJ44015B: UDI/DI 10193489215939 (each) 40193489215930 (case), Lot Number 23EMD927A; 58) Pack Number DYNJ45048C: UDI/DI 10193489808889 (each) 40193489808880 (case), Lot Number 21IMD394A; 59) Pack Number DYNJ0394805N: UDI/DI 10193489245240 (each) 40193489245241 (case), Lot Number 23LME396A; 60) Pack Number DYNJ33544L: UDI/DI 10195327279318 (each) 40195327279319 (case), Lot Number 23LMF755A; 61) Pack Number DYNJ0394730P: UDI/DI 10193489430943 (each) 40193489430944 (case), Lot Number 21LMG091A; 62) Pack Number DYNJ58386A: UDI/DI 10193489397468 (each) 40193489397469 (case), Lot Number 21VBB871A; 63) Pack Number DYNJ80309: UDI/DI 10195327023218 (each) 40195327023219 (case), Lot Number 23LMF645A; 64) Pack Number DYNJ45376G: UDI/DI 10195327209353 (each) 40195327209354 (case), Lot Number 23KMD075A; 65) Pack Number DYNJ48288C: UDI/DI 10888277745599 (each) 40888277745590 (case), Lot Number 21IMH225A; 66) Pack Number DYNJ54979: UDI/DI 10889942519910 (each) 40889942519911 (case), Lot Number 21LBL535Z; 67) Pack Number DYNJ64883C: UDI/DI 10193489369670 (each) 40193489369671 (case), Lot Number 23BBR373A; 68) Pack Number DYNJ43945I: UDI/DI 10193489704242 (each) 40193489704243 (case), Lot Number 23GME703A; 69) Pack Number DYNJ43945I: UDI/DI 10193489704242 (each) 40193489704243 (case), Lot Number 23HMC425A; 70) Pack Number DYNJ67426A: UDI/DI 10195327049317 (each) 40195327049318 (case), Lot Number 23HMC554A; 71) Pack Number DYNJ41863C: UDI/DI 10195327463632 (each) 40195327463633 (case), Lot Number 23HBW577A; 72) Pack Number DYNJ60681A: UDI/DI 10193489780819 (each) 40193489780810 (case), Lot Number 20EBI994A; 73) Pack Number DYNJ60681A: UDI/DI 10193489780819 (each) 40193489780810 (case), Lot Number 21BBI579A | Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution Worldwide distribution - US Nationwide and the country of Canada. States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## Dates in the source - **Report date**: Apr 2, 2025 - **Recall initiation date**: Feb 11, 2025 - **Center classification date**: Mar 25, 2025 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1438-2025%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [MEDLINE INDUSTRIES, LP - Northfield records](https://isitonrecall.com/brand/medline-industries-lp-northfield/)