M Dialysis AB

Manufacturer

🇸🇪 Sweden

M DIALYSIS AB

FDA registration

M DIALYSIS AB·3 products·🇸🇪 Sweden

ISCUS FLEX MICRODIALYSIS ANALYZER

FDA Adverse Event

Injury ·M DIALYSIS INC., AB·Product code PPM·August 14, 2018

NATURALYTE 2251 2K 2.5CA

FDA Adverse Event

Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·April 30, 2015

NATURALYTE BICARBONATE

FDA Adverse Event

Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·April 30, 2015

PD CATHETER

FDA Adverse Event

Injury ·UNK·Product code FJS·August 22, 2023

NXSTAGE SYSTEM ONE

FDA Adverse Event

Injury ·NXSTAGE MEDICAL, INC.·Product code KDI·August 21, 2020

GORE EXCLUDER AAA ENDOPROSTHESIS

FDA Adverse Event

Injury ·W.L. GORE & ASSOCIATES·Product code MIH·May 28, 2013

EVOLUT PRO TRANSCATHETER AORTIC VALVE

FDA Adverse Event

Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·December 5, 2022

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event

Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·May 26, 2011

Medline Kits, trays, and packs labeled as follows: a) 709E RECOVERY PACK A,B,C II SS, REF DYNJ55960G; b) ABDOMEN PACK, REF DYNJ53643C; c) BAG TRUNK STOCK KIT, REF DYKM1880; d) BEDSIDE BRONCH PACK, REF DYKE1601; e) BIOPSY TRAY, REF DYNDH1242; f) BRONCH KIT, REF DYKE1840; g) BRONCHOSCOPY PACK, REF DYNJ37775F; h) BRONCHOSCOPY TRAY, REF DYNDL1350A; i) BRONCHOSCOPY TRAY, REF DYNDL1350AH; j) CAP CHANGE LARGE KIT, REF DYNDA2277A; k) CAP CHANGE LARGE KIT, REF DYNDA2277B; l) DAILY VAD DRIVELINE KIT, REF DYNDC3006; m) DAILY VENT KIT, REF DYNDJ1076; n) DIALYSIS OFF KIT, REF DT21230A; o) DIALYSIS OFF KIT, REF DT20350B; p) DIALYSIS ON KIT, REF DT20355B; q) DOUBLE HUB/CAP CHANGE KIT, REF DYNDC2843; r) DR D CUSTOM PACK, REF DYNJ68068A; s) DR D CUSTOM PACK, REF DYNJ68068B; t) DUODENUM CULTURING PACK, REF DYNJ51294; u) EGD SOUTHEASTERN REG KIT, REF DYKE1830; v) EMERGENCY UMBILICAL INSERTION, REF UVT1165; w) ENDO KIT, REF DYKE1069B; x) ENDO KIT, REF DYKE1475B; y) ERCP ENDO KIT, REF P604360B; z) ERCP SOUTHEASTERN REG KIT, REF DYKM2127; aa) FACIAL PLASTY PACK, REF DYNJ55335D; bb) FIRST YEAR KIT LF, REF EDUC1037; cc) FOLEY BULB INDUCTION KIT, REF MNS13545; dd) G BUNDLE CDS, REF CDS982759; ee) GBMC ULTRASOUND GUIDED PIV KIT, REF DYNDV2330B; ff) GBMC ULTRASOUND GUIDED PIV KIT, REF DYNDV2330C; gg) GENERAL/HERNIA PACK, REF DYNJ38541B; hh) GI BRONCHOSCOPY KIT, REF DYKE1254C; ii) HH CAR STOCK IN BIN, REF DYKM1883; jj) IMMERSION 4, REF EDUC05059A; kk) KIT LINE INSERTION, REF CVI4730; ll) KIT, PEG, SOUTHEASTERN REG, REF DYKM2128; mm) LINE INSERT PACK, REF PHS422216004C; nn) MANUAL BLADDER IRRIGATION KIT, REF UROT1051; oo) MANUAL BLADDER IRRIGATION KIT1, REF UROT1051A; pp) MANUAL BLADDER IRRIGATION KIT1, REF UROT1051AH; qq) MOHS KIT, REF DYNDA2072A; rr) MULTI LUMEN CAP CHANGE, REF DYNDA2390A; ss) N HOME CARE WOUND KIT, REF DYK1188079W; tt) NURSE KIT NO LOGO-LF, REF EDUC05036; uu) NURSE TOTE, REF DYKM1872A; vv) NURSING SKILLS, REF EDUC05015A; ww) PICC, REF CDS980470D; xx) PRE OP KIT, REF DYKS1262A; yy) PULMONARY SETUP KIT, REF DYNDA2648; zz) PULMONARY SETUP KIT, REF DYNDA2648H; aaa) REDDY JOINT BATH, REF MMJB001; bbb) REDDY JOINT BATH, REF MMJB001A; ccc) RNSG 1441, REF EDUC1029; ddd) RNSG 1441, REF EDUC1029H; eee) RNSG 2201, REF EDUC1034; fff) RNSG 2201, REF EDUC1034H; ggg) SENSITIVE SKIN WEEKLY VAD, REF DYNDC3185; hhh) SHEATH REMOVAL TRAY, REF DYNDC1311C; iii) SHORT TERM KIT, REF DYNDC3092; jjj) SINGLE HUB/CAP CHANGE KIT, REF DYNDC2841; kkk) STERILE CAP CHANGE, REF DYNDA2387A; lll) STERILE PREP KIT, REF DYNDA1359; mmm) STERILE PREP KIT, REF DYNDA1359A; nnn) STRL EK SINGLE PACK, REF DYNDA1360B; ooo) SUB PORT ACCESS TRAY, REF DYNDC2768A; ppp) SUPRA PUBIC IRRIGATION TRAY ST, REF DYNDT1019; qqq) SURGICAL PREP KIT, REF DYNJ46340B; rrr) SUTURE KIT, REF M101494; sss) SUTURE TRAY, REF DYNDS1085A; ttt) TRUNK KIT, REF DYKTRUNK1; uuu) TRUNK KIT 1EA, REF DYKM2013; vvv) UMBILICAL VESSEL INSERTION, REF DYNDA3011; www) URINALYSIS KIT, REF DYKM1251; xxx) VAD ACCESS CHANGE KIT, REF DYNDC2882B; yyy) VAD DRESSING KIT A, REF DYNDA2164; zzz) CENTRAL BLOOD CULTURE KIT, REF DYNDH1342B; aaaa) CVC DRESSING CHANGE KIT, REF EBSI1552; bbbb) PORT ACCESS POWER LOC KIT, REF DYNDC1712B; cccc) PORT ACCESS TRAY, REF DYNDC1128B;

FDA Recall

Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code LRO·November 15, 2023

Medline Kits, trays, and packs labeled as follows: a) 709E RECOVERY PACK A,B,C II SS, REF DYNJ55960G; b) ABDOMEN PACK, REF DYNJ53643C; c) BAG TRUNK STOCK KIT, REF DYKM1880; d) BEDSIDE BRONCH PACK, REF DYKE1601; e) BIOPSY TRAY, REF DYNDH1242; f) BRONCH KIT, REF DYKE1840; g) BRONCHOSCOPY PACK, REF DYNJ37775F; h) BRONCHOSCOPY TRAY, REF DYNDL1350A; i) BRONCHOSCOPY TRAY, REF DYNDL1350AH; j) CAP CHANGE LARGE KIT, REF DYNDA2277A; k) CAP CHANGE LARGE KIT, REF DYNDA2277B; l) DAILY VAD DRIVELINE KIT, REF DYNDC3006; m) DAILY VENT KIT, REF DYNDJ1076; n) DIALYSIS OFF KIT, REF DT21230A; o) DIALYSIS OFF KIT, REF DT20350B; p) DIALYSIS ON KIT, REF DT20355B; q) DOUBLE HUB/CAP CHANGE KIT, REF DYNDC2843; r) DR D CUSTOM PACK, REF DYNJ68068A; s) DR D CUSTOM PACK, REF DYNJ68068B; t) DUODENUM CULTURING PACK, REF DYNJ51294; u) EGD SOUTHEASTERN REG KIT, REF DYKE1830; v) EMERGENCY UMBILICAL INSERTION, REF UVT1165; w) ENDO KIT, REF DYKE1069B; x) ENDO KIT, REF DYKE1475B; y) ERCP ENDO KIT, REF P604360B; z) ERCP SOUTHEASTERN REG KIT, REF DYKM2127; aa) FACIAL PLASTY PACK, REF DYNJ55335D; bb) FIRST YEAR KIT LF, REF EDUC1037; cc) FOLEY BULB INDUCTION KIT, REF MNS13545; dd) G BUNDLE CDS, REF CDS982759; ee) GBMC ULTRASOUND GUIDED PIV KIT, REF DYNDV2330B; ff) GBMC ULTRASOUND GUIDED PIV KIT, REF DYNDV2330C; gg) GENERAL/HERNIA PACK, REF DYNJ38541B; hh) GI BRONCHOSCOPY KIT, REF DYKE1254C; ii) HH CAR STOCK IN BIN, REF DYKM1883; jj) IMMERSION 4, REF EDUC05059A; kk) KIT LINE INSERTION, REF CVI4730; ll) KIT, PEG, SOUTHEASTERN REG, REF DYKM2128; mm) LINE INSERT PACK, REF PHS422216004C; nn) MANUAL BLADDER IRRIGATION KIT, REF UROT1051; oo) MANUAL BLADDER IRRIGATION KIT1, REF UROT1051A; pp) MANUAL BLADDER IRRIGATION KIT1, REF UROT1051AH; qq) MOHS KIT, REF DYNDA2072A; rr) MULTI LUMEN CAP CHANGE, REF DYNDA2390A; ss) N HOME CARE WOUND KIT, REF DYK1188079W; tt) NURSE KIT NO LOGO-LF, REF EDUC05036; uu) NURSE TOTE, REF DYKM1872A; vv) NURSING SKILLS, REF EDUC05015A; ww) PICC, REF CDS980470D; xx) PRE OP KIT, REF DYKS1262A; yy) PULMONARY SETUP KIT, REF DYNDA2648; zz) PULMONARY SETUP KIT, REF DYNDA2648H; aaa) REDDY JOINT BATH, REF MMJB001; bbb) REDDY JOINT BATH, REF MMJB001A; ccc) RNSG 1441, REF EDUC1029; ddd) RNSG 1441, REF EDUC1029H; eee) RNSG 2201, REF EDUC1034; fff) RNSG 2201, REF EDUC1034H; ggg) SENSITIVE SKIN WEEKLY VAD, REF DYNDC3185; hhh) SHEATH REMOVAL TRAY, REF DYNDC1311C; iii) SHORT TERM KIT, REF DYNDC3092; jjj) SINGLE HUB/CAP CHANGE KIT, REF DYNDC2841; kkk) STERILE CAP CHANGE, REF DYNDA2387A; lll) STERILE PREP KIT, REF DYNDA1359; mmm) STERILE PREP KIT, REF DYNDA1359A; nnn) STRL EK SINGLE PACK, REF DYNDA1360B; ooo) SUB PORT ACCESS TRAY, REF DYNDC2768A; ppp) SUPRA PUBIC IRRIGATION TRAY ST, REF DYNDT1019; qqq) SURGICAL PREP KIT, REF DYNJ46340B; rrr) SUTURE KIT, REF M101494; sss) SUTURE TRAY, REF DYNDS1085A; ttt) TRUNK KIT, REF DYKTRUNK1; uuu) TRUNK KIT 1EA, REF DYKM2013; vvv) UMBILICAL VESSEL INSERTION, REF DYNDA3011; www) URINALYSIS KIT, REF DYKM1251; xxx) VAD ACCESS CHANGE KIT, REF DYNDC2882B; yyy) VAD DRESSING KIT A, REF DYNDA2164; zzz) CENTRAL BLOOD CULTURE KIT, REF DYNDH1342B; aaaa) CVC DRESSING CHANGE KIT, REF EBSI1552; bbbb) PORT ACCESS POWER LOC KIT, REF DYNDC1712B; cccc) PORT ACCESS TRAY, REF DYNDC1128B;

FDA Enforcement

Class I ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·March 6, 2024

Medline procedure packs containing Shenli syringes, labeled as follows: 1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B ; 2) DIALYSIS PACK , Pack Number DYNJ36932A ; 3) DIALYSIS AV SHUNT #668229-V-LF, Pack Number DYNJ58502C ; 4) DIALYSIS ACCESS PACK, Pack Number DYNJ910121 ; 5) NO CATH DIALYSIS INSERTN TRAY , Pack Number PICCNC0028

FDA Enforcement

Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 4, 2024

Medline Convenience kits labeled as: 1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B ; 2) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516BH; 3) DIALYSIS PACK , Pack Number DYNJ36932A ; 4) DIALYSIS AV SHUNT #668229-V-LF, Pack Number DYNJ58502C ; 5) DIALYSIS ACCESS PACK, Pack Number DYNJ910121 ; 6) NO CATH DIALYSIS INSERTN TRAY , Pack Number PICCNC0028

FDA Enforcement

Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024

Medline procedure packs containing Shenli syringes, labeled as follows: 1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B ; 2) DIALYSIS PACK , Pack Number DYNJ36932A ; 3) DIALYSIS AV SHUNT #668229-V-LF, Pack Number DYNJ58502C ; 4) DIALYSIS ACCESS PACK, Pack Number DYNJ910121 ; 5) NO CATH DIALYSIS INSERTN TRAY , Pack Number PICCNC0028

FDA Recall

Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code PEV·April 8, 2024

Medline Convenience kits labeled as: 1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B ; 2) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516BH; 3) DIALYSIS PACK , Pack Number DYNJ36932A ; 4) DIALYSIS AV SHUNT #668229-V-LF, Pack Number DYNJ58502C ; 5) DIALYSIS ACCESS PACK, Pack Number DYNJ910121 ; 6) NO CATH DIALYSIS INSERTN TRAY , Pack Number PICCNC0028

FDA Recall

Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code PEV·April 8, 2024

FRESENIUS LIBERTY CYCLER

FDA Adverse Event

Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·September 5, 2014

LIBERTY CYCLER

FDA Adverse Event

Malfunction ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·April 1, 2016

FRESENIUS 2008K

FDA Adverse Event

Death ·FRESENIUS USA, INC·Product code KDI·September 16, 2013

LIBERTY CYCLER

FDA Adverse Event

Malfunction ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·November 25, 2015