United StatesMultiple Medline products are affected, including Medline Namic guidewires, Medline Namic and Medline syringes, and numerous Medline angio/catheter kits; affected items are identified by the specific model numbers, UDI-DIs, and lot numbers listed in the notice and were distributed nationwide in the U.S. The recall was initiated because the 510(k) regulatory clearances for certain control syringes, guidewires, and/or high‑pressure tubing have been rescinded.
What's being recalled
Medline Namic Guidewires: 1) GUIDEWIRE 3MMJ 0.035X260CM LT, Model Number: DYNJGWIRE20L; 2) GWIRE HYDRO 0.035 180CM ANG S, Model Number: DYNJHWIRE105; 3) GWIRE HYDRO 0.035 260CM ANG S, Model Number: DYNJHWIRE107; 4) GWIRE HYDRO 0.035 260CM STR S, Model Number: DYNJHWIRE115; 5) GWIRE HYDRO 0.035 150CM STR, Model Number: DYNJHWIRE108; 6) GWIRE HYDRO 0.035 150CM ANG S, Model Number: DYNJHWIRE104; 7) GWIRE HYDRO 0.035 180CM STR S, Model Number: DYNJHWIRE113; 8) GWIRE HYDRO 0.035 260CM ANGLE, Model Number: DYNJHWIRE103; 9) GDWIRE .035INX150CM 3MMJ LT, Model Number: DYNJGWIRE01L; 10) GDWIRE .035INX180CM 3MMJ LT, Model Number: DYNJGWIRE03L; 11) GWIRE HYDRO 0.035 150CM STR S, Model Number…
Medline Namic Syringes: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB;
Medline Syringes: 1) SYRINGE 12ML CONTROL W/ROTATOR, Model Number: DYNJSYR12CWR; 2) SYRINGE 10ML CONTROL W/ROTATOR, Model Number: DYNJSYR10CWR; 3) SYR CONTROL PAD 12ML L/L, Model Number: DYNJSYR12CP; 4) TBG PRESS 72IN M/F ROT BRAID, Model Number: DYNJBRT72R; 5) SYRINGE 10ML CONTROL MLL, Model Number: DYNJSYR10C; 6) SYRINGE 8ML CONTROL MLL, Model Number: DYNJSYR8C; 7) SYRINGE 12ML CONTROL MLL, Model Number: DYNJSYR12C; 8) SYR CONTROL PAD 10ML L/L ROT, Model Number: DYNJSYR10CRP; 9) SYR CONTROL PAD 12ML L/L ROT, Model Number: DYNJSYR12CRP; 10) CTRL SYRINGE 6ML RING ROT L/L, Model Number: DYNJSYRC6CWR
Medline Kits: 1) ANGIO CATH PACK-MARY IMMACULAT, Model Number: DYNJ24517D
Medline Kits: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB; 2) MANIFOLD KIT LOW PRESSURE OFF, Model Number: VASCSLPOFF1; 3) EP MANIFOLD KIT, Model Number: VASC1018A
Medline Kits: 1) ANGIOGRAPHY PACK-LF, Model Number: DYNJQ0505M; 2) ANGIO PACK, Model Number: DYNJT2021G; 3) ANGIOGRAPHY PACK, Model Number: DYNJ31377B; 4) ANGIO PACK, Model Number: DYNJ51279; 5) ANGIOGRAPHY PACK II, Model Number: DYNJ52447; 6) CATH ANGIO PACK, Model Number: DYNJ53369C; 7) ANGIO PACK, Model Number: DYNJ53591A; 8) ANGIOGRAPHIC PACK, Model Number: DYNJ57516; 9) ANGIOGRAPHY TRAY-LF, Model Number: DYNJ58722A; 10) ANGIO TRAY W/CHLORAPREP, Model Number: DYNJ62742; 11) CEREBRAL ANGIOGRAM, Model Number: DYNJ67876; 12) CSU CATH MANIFOLD KIT, Model Number: VASC1170A
Medline Kits: 1) CATH LAB CDS, Model Number: CDS840228F; 2) IR PACK, Model Number: DYNDH2104; 3) CARDIAC CATH PACK-LF, Model Number: DYNJT2164M; 4) ANGIOGRAPHY TRAY, Model Number: DYNJT3078; 5) CATH PACK, Model Number: DYNJT4190; 6) ANGIO VASCULAR PACK, Model Number: DYNJT5717; 7) HEART CATH PACK, Model Number: DYNJ0381139R; 8) CARDIAC CATH PACK, Model Number: DYNJ04529L; 9) CUSTOM RADIOLOGY PACK, Model Number: DYNJ07955L; 10) STVZ CARDIAC CATH PACK, Model Number: DYNJ24619J; 11) CATH TRAY #2, Model Number: DYNJ24706D; 12) CATH LAB PACK, Model Number: DYNJ24802Q; 13) CATH PACK, Model Number: DYNJ30268K; 14) HEART CATHETERIZATION PACK, Model Number: DYNJ30927R; 15) HEART CATH TRAY PACK-LF…
Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; 2) DBD-MTS LHK BHS BAPTIST. LOUISVI, Model Number: 60022026; 3) MTO LEFT HEART KIT SUMMA BARBERT, Model Number: 60022673; 4) MTS LH KIT-UNIV OF MIAMI PG, Model Number: 60030817; 5) MTS LEFT HEART KIT SPRINGFIELD R, Model Number: 60031245; 6) MTS PERIPHERAL KIT SPRINGFIELD R, Model Number: 60031247; 7) MTS LEFT HEART KIT-COLISEUM MED, Model Number: 60031928; 8) MTS LEFT HEART KIT -2-CALIFORNIA, Model Number: 60033011; 9) MTS LEFT HEART KIT JOHN MUIR CON, Model Number: 60040273; 10) MTS EP MANIFOLD KIT TEXAS HLTH P, Model Number: 60041268; 11) MTS 3V MANIFOLD KIT-SPARROW HOSP, Model Number: 60050097; 12) MTS LEFT…
Medline Kits: 1) PICC TRAY, Model Number: DYNJ41648A
Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A
Medline Kits: 1) ENT PACK, Model Number: DYNJ59030B; 2) ENT, Model Number: DYNJ908586C; 3) LH 3 PORT W/O WASTEBAG, Model Number: VASC1081C
Medline Kits: 1) GENERAL LAPAROSCOPY, Model Number: CDS930027Y
Medline Kits: 1) BREAST PACK, Model Number: DYNJ66777D
Medline Kits: 1) NEWBORN ADMISSION, Model Number: DYKB1038; 2) DRAINAGE TRAY, Model Number: DYNDA3188; 3) VA ORLANDO SHOULDER PACK, Model Number: DYNJG001027B; 4) TUMESCENT SYRINGE KIT, Model Number: DYNJTUMSYR; 5) OMC PTCA PACK, Model Number: DYNJT3719; 6) PORT PACK, Model Number: DYNJT5667; 7) WASTE MANAGEMENT KIT - 2, Model Number: DYNJWASTEKIT2; 8) CARDIAC CATH, Model Number: DYNJ20175J; 9) D&C PACK-POB, Model Number: DYNJ33521D; 10) BASIC PACK, Model Number: DYNJ38533F; 11) CATH PACK IMPLANT, Model Number: DYNJ39230D; 12) CERVICAL SPINE PACK, Model Number: DYNJ40886B; 13) MV-IR ANGIO DRAPE PACK-LF, Model Number: DYNJ41553F; 14) TV ENDOVASCULAR-LF, Model Number: DYNJ41558D; 15) MAJOR…
Medline Kits: 1) SYR CONTROL 8ML ROTATING, Model Number: DNSC89369; 2) SYRINGE 10ML CONTROL MLL, Model Number: DYNJSYR10C
And 7 more products.
Recalling firm: Medline Industries, LP, Northfield, IL, United States.
How to identify it
1) DYNJGWIRE20L, UDI-DI: 10195327188955(each), 40195327188956(case), Lot Number: 34125030001; 2) DYNJGWIRE20L, UDI-DI: 10195327188955(each), 40195327188956(case), Lot Number: 34125040001; 3) DYNJGWIRE20L, UDI-DI: 10195327188955(each), 40195327188956(case), Lot Number: 25DBG562; 4) DYNJGWIRE20L, UDI-DI: 10195327188955(each), 40195327188956(case), Lot Number: 25DBM956; 5) DYNJHWIRE105, UDI-DI: 10195327301637(each), 40195327301638(case), Lot Number: 34124110001; 6) DYNJHWIRE105, UDI-DI: 10195327301637(each), 40195327301638(case), Lot Number: 24LBR925; 7) DYNJHWIRE105, UDI-DI: 10195327301637(each), 40195327301638(case), Lot Number: 25IDB410; 8) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 34124110001; 9) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 23IBI440; 10) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 23KBI254; 11) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 24ABQ057; 12) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 24ABR513; 13) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 24GBL513; 14) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 25JDA853; 15) DYNJHWIRE115, UDI-DI: 10195327306021(each), 40195327306022(case), Lot Number: 34124110001; 16) DYNJHWIRE115, UDI-DI: 10195327306021(each), 40195327306022(case), Lot Number: 23BBI300; 17) DYNJHWIRE115, UDI-DI: 10195327306021(each), 40195327306022(case), Lot Number: 24DBT361; 18) DYNJHWIRE115, UDI-DI: 10195327306021(each), 40195327306022(case), Lot Number: 24LBN513; 19) DYNJHWIRE108, UDI-DI: 10195327302191(each), 40195327302192(case), Lot Number: 34124110001; 20) DYNJHWIRE108, UDI-DI: 10195327302191(each), 40195327302192(case), Lot Number: 24DBG409; 21) DYNJHWIRE108, UDI-DI: 10195327302191(each), 40195327302192(case), Lot Number: 24DBI536; 22) DYNJHWIRE108, UDI-DI: 10195327302191(each)…
The hazard
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)