| | Class 2 Device Recall Medline |  |
| Date Initiated by Firm | April 08, 2024 |
|---|
| Date Posted | September 06, 2024 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2983-2024 |
|---|
| Recall Event ID |
94583 |
| Product Classification |
Circuit, breathing (w connector, adaptor, y piece) - Product Code CAI
|
| Product | Medline Convenience kits, labeled as:
1) GAS SAM LINE .06ID 10FT MM FLT, Pack Number 35772 ;
2) ANES CIRC 90 EXP PEDS 2BV-LF, Pack Number 81842 ;
3) AIRWAY EXAM KIT, Pack Number DYKE1796 ;
4) INTUBATION KIT , Pack Number DYKSCRIPPSIN4;
5) INTUBATION KIT , Pack Number DYNDA1598C;
6) INTUBATION KIT , Pack Number DYNDA1598CH ;
7) ANESTHESIA KIT , Pack Number DYNDA2958;
8) ANESTHESIA PREP CUSTOM TRAY, Pack Number DYNDH1758;
9) ADULT LUMBAR PUNCTURE TRAY , Pack Number DYNDH1889;
10) PEDIATRIC CARDIAC PACK-LF, Pack Number DYNJ0537013Y;
11) PEDIATRIC MINOR PK, Pack Number DYNJ49035B;
12) WMC PEDIATRIC ADD ON PACK-LF, Pack Number DYNJ50644;
13) ANESTHESIA CVL KIT-LF, Pack Number DYNJ52283B;
14) ANESTHESIA CVL KIT-LF, Pack Number DYNJ52283C;
15) AIRWAY PACK , Pack Number DYNJ60239B;
16) ANESTHESIA PAIN PK LEAGUE, Pack Number DYNJ67925;
17) H-CABG INTRA OP ANESTHESIA , Pack Number DYNJ900603I ;
18) H-CABG INTRA OP ANESTHESIA , Pack Number DYNJ900603J ;
19) CV ANESTHESIA - ROOM SET UP, Pack Number DYNJ905503A ;
20) CV ANESTHESIA - ROOM SET UP, Pack Number DYNJ905503B ;
21) CV ANESTHESIA - ROOM SET UP, Pack Number DYNJ905503C ;
22) CV ANESTHESIA - ROOM SET UP, Pack Number DYNJ905503D ;
23) CV ANESTHESIA - ROOM SET UP, Pack Number DYNJ905503F ;
24) #######, Pack Number DYNJ905503F ;
25) MZ MDL AIRWAY, Pack Number DYNJ910129;
26) ANESTHESIA CIRCUIT-LF, Pack Number DYNJAA10379 ;
27) ANESTHESIA CIRCUIT-LF, Pack Number DYNJAA6572;
28) ANESTHESIA EVALUATION SAMPLE, Pack Number DYNJAASAMPLE;
29) ANESTHESIA EVALUATION SAMPLE, Pack Number DYNJAASAMPLE;
30) REGIONAL ANESTHESIA PREP TRAY , Pack Number DYNJRA0376A ;
31) ANESTHESIA KIT , Pack Number DYNJRA0424A ;
32) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA0767;
33) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA0767A ;
34) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA0767B ;
35) ANESTHESIA SUPPORT TRAY , Pack Number DYNJRA0779A ;
36) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA0887A ;
37) ANESTHESIA TRAY, Pack Number DYNJRA0909;
38) SPINAL ANESTHESIA TRAY/WHITE, Pack Number DYNJRA0955A ;
39) #####, Pack Number DYNJRA0955A ;
40) ANESTHESIA SUPPORT TRAY/B, Pack Number DYNJRA0968;
41) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA1119;
42) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA1119A ;
43) ANESTHESIA TRAY, Pack Number DYNJRA1355;
44) ANESTHESIA TRAY, Pack Number DYNJRA1355A ;
45) SPINAL ANESTHESIA TRAY, Pack Number DYNJRA1577A ;
46) ANESTHESIA SUPPORT TRAY/CHLORA, Pack Number DYNJRA1659;
47) ANESTHESIA SUPPORT TRAY/CHLORA, Pack Number DYNJRA1659A ;
48) SPINAL ANESTHESIA TRAY, Pack Number DYNJRA1757;
49) ANESTHESIA PREP KIT, Pack Number DYNJRA1899;
50) ANESTHESIA TRAY, Pack Number DYNJRA1934;
51) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA2087;
52) SPINAL ANESTHESIA TRAY, Pack Number DYNJRA2151;
53) PRE OP ANES KIT, Pack Number DYNJRA2228;
54) PRE OP ANES KIT, Pack Number DYNJRA2228H;
55) CUSTOM ANESTHESIA KIT-LF, Pack Number GSP478I;
56) REGIONAL TRAY, Pack Number PAIN0385B;
57) EPIDURAL ANESTHESIA KIT , Pack Number PAIN1982 ;
58) CIRC PACK-LF, Pack Number PHS41720I;
59) CIRC PACK-LF, Pack Number PHS41720J;
60) ANES CIRC 90 EXP, Pack Number VM96DLEX2L |
|---|
| Code Information |
35772, Lot Number 19GBK969 ;
81842, Lot Number 20JBS956 ;
DYKE1796 , Lot Number 21GBR139 ;
DYKE1796 , Lot Number 22HBX360 ;
DYKE1796 , Lot Number 22JBR572 ;
DYKSCRIPPSIN4, Lot Number 19DAA326 ;
DYKSCRIPPSIN4, Lot Number 19EAA345 ;
DYKSCRIPPSIN4, Lot Number 19HAB271 ;
DYKSCRIPPSIN4, Lot Number 19LAA719 ;
DYKSCRIPPSIN4, Lot Number 20AAA102 ;
DYKSCRIPPSIN4, Lot Number 20BAA611 ;
DYKSCRIPPSIN4, Lot Number 20DAA064 ;
DYNDA1598C , Lot Number 23KMF159 ;
DYNDA1598C , Lot Number 24AMG428 ;
DYNDA1598CH, Lot Number 23KMF159 ;
DYNDA1598CH, Lot Number 24AMG428 ;
DYNDA2958, Lot Number 22KBH750 ;
DYNDH1758, Lot Number 22HBX410 ;
DYNDH1758, Lot Number 22JBU749 ;
DYNDH1758, Lot Number 22LBK163 ;
DYNDH1889, Lot Number 23HBZ539 ;
DYNDH1889, Lot Number 23KBG134 ;
DYNJ0537013Y , Lot Number 21LMD783 ;
DYNJ49035B , Lot Number 19BDA167 ;
DYNJ49035B , Lot Number 19CDC764 ;
DYNJ49035B , Lot Number 19EDD455 ;
DYNJ49035B , Lot Number 19GDC256 ;
DYNJ49035B , Lot Number 19IDC024 ;
DYNJ49035B , Lot Number 20ADA825 ;
DYNJ49035B , Lot Number 20BDC864 ;
DYNJ49035B , Lot Number 20DDA660 ;
DYNJ49035B , Lot Number 20GDB084 ;
DYNJ49035B , Lot Number 20IDB475 ;
DYNJ49035B , Lot Number 20LDA638 ;
DYNJ50644, Lot Number 21KBE704 ;
DYNJ50644, Lot Number 22OBH075 ;
DYNJ50644, Lot Number 22HBD748 ;
DYNJ50644, Lot Number 19HBZ833 ;
DYNJ50644, Lot Number 19JBI231 ;
DYNJ50644, Lot Number 19VBB145 ;
DYNJ50644, Lot Number 20BBB196 ;
DYNJ50644, Lot Number 23JBW861 ;
DYNJ52283B , Lot Number 19ABX422 ;
DYNJ52283B , Lot Number 19BBT964 ;
DYNJ52283C , Lot Number 21IBF288 ;
DYNJ52283C , Lot Number 21JBX031 ;
DYNJ52283C , Lot Number 21LBB738 ;
DYNJ52283C , Lot Number 22ABA824 ;
DYNJ52283C , Lot Number 22OBI904 ;
DYNJ52283C , Lot Number 19DBO272 ;
DYNJ52283C , Lot Number 19DBU670 ;
DYNJ52283C , Lot Number 19FBM983 ;
DYNJ52283C , Lot Number 22HBE294 ;
DYNJ52283C , Lot Number 19GBL569 ;
DYNJ52283C , Lot Number 19GBW600 ;
DYNJ52283C , Lot Number 19SBC949 ;
DYNJ52283C , Lot Number 22JBN210 ;
DYNJ52283C , Lot Number 19JBT368 ;
DYNJ52283C , Lot Number 19JBV109 ;
DYNJ52283C , Lot Number 19VBH492 ;
DYNJ52283C , Lot Number 19KBJ678 ;
DYNJ52283C , Lot Number 19KBN283 ;
DYNJ52283C , Lot Number 23BBU977 ;
DYNJ52283C , Lot Number 19LBK922 ;
DYNJ52283C , Lot Number 19LBS004 ;
DYNJ52283C , Lot Number 20ABM461 ;
DYNJ52283C , Lot Number 20ABP865 ;
DYNJ52283C , Lot Number 23EBL084 ;
DYNJ52283C , Lot Number 20BBJ414 ;
DYNJ52283C , Lot Number 20BBS280 ;
DYNJ52283C , Lot Number 23FBP678 ;
DYNJ52283C , Lot Number 23HBK734 ;
DYNJ52283C , Lot Number 20HBH238 ;
DYNJ52283C , Lot Number 20JBJ550 ;
DYNJ52283C , Lot Number 20JBN445 ;
DYNJ52283C , Lot Number 20KBA832 ;
DYNJ52283C , Lot Number 20KBP071 ;
DYNJ52283C , Lot Number 21ABN133 ;
DYNJ60239B , Lot Number 23LDA663 ;
DYNJ67925, Lot Number 21GBR614 ;
DYNJ67925, Lot Number 21JBL671 ;
DYNJ67925, Lot Number 21LBO778 ;
DYNJ67925, Lot Number 21LBO779 ;
DYNJ67925, Lot Number 21LBO780 ;
DYNJ67925, Lot Number 21LBO781 ;
DYNJ67925, Lot Number 22ABA751 ;
DYNJ67925, Lot Number 22ABQ043 ;
DYNJ67925, Lot Number 22BBL497 ;
DYNJ67925, Lot Number 22GBR405 ;
DYNJ67925, Lot Number 22HBF644 ;
DYNJ67925, Lot Number 22IBQ399 ;
DYNJ67925, Lot Number 22KBU314 ;
DYNJ67925, Lot Number 23ABO072 ;
DYNJ67925, Lot Number 23ABT720 ;
DYNJ67925, Lot Number 23CBF754 ;
DYNJ67925, Lot Number 23DBP494 ;
DYNJ67925, Lot Number 23FBJ744 ;
DYNJ67925, Lot Number 23GBQ403 ;
DYNJ67925, Lot Number 23HBE106 ;
DYNJ67925, Lot Number 21ABA903 ;
DYNJ67925, Lot Number 21ABW854 ;
DYNJ67925, Lot Number 21DBP686 ;
DYNJ67925, Lot Number 21EBH092 ;
DYNJ900603I, Lot Number 20DDB314 ;
DYNJ900603I, Lot Number 20FDB651 ;
DYNJ900603I, Lot Number 20GDA926 ;
DYNJ900603I, Lot Number 20HDA245 ;
DYNJ900603I, Lot Number 20JDB313 ;
DYNJ900603I, Lot Number 20JDB761 ;
DYNJ900603I, Lot Number 20LDB998 ;
DYNJ900603I, Lot Number 21ADB434 ;
DYNJ900603I, Lot Number 21BDA664 ;
DYNJ900603J, Lot Number 21HDC941 ;
DYNJ900603J, Lot Number 21IDB264 ;
DYNJ905503A, Lot Number 19CBB091 ;
DYNJ905503A, Lot Number 19DBG305 ;
DYNJ905503A, Lot Number 19PBB724 ;
DYNJ905503A, Lot Number 19QBB679 ;
DYNJ905503B, Lot Number 19FBZ308 ;
DYNJ905503B, Lot Number 19HBV183 ;
DYNJ905503B, Lot Number 19IBY178 ;
DYNJ905503B, Lot Number 19LBP039 ;
DYNJ905503C, Lot Number 20MBA222 ;
DYNJ905503C, Lot Number 20CBF593 ;
DYNJ905503C, Lot Number 20EBK549 ;
DYNJ905503C, Lot Number 20EBO464 ;
DYNJ905503C, Lot Number 20HBU177 ;
DYNJ905503D, Lot Number 21FBN751 ;
DYNJ905503D, Lot Number 20LBP237 ;
DYNJ905503D, Lot Number 21DBG611 ;
DYNJ905503D, Lot Number 21EBI605 ;
DYNJ905503F, Lot Number 21HBL060 ;
DYNJ905503F, Lot Number 21IBW859 ;
DYNJ905503F, Lot Number 22DBC340 ;
DYNJ905503F, Lot Number 22DBS437 ;
DYNJ905503F, Lot Number 22FBR267 ;
DYNJ905503F, Lot Number 22GBR286 ;
DYNJ905503F, Lot Number 22HBS560 ;
DYNJ905503F, Lot Number 22IBA577 ;
DYNJ905503F, Lot Number 22JBI883 ;
DYNJ905503F, Lot Number 22KBD587 ;
DYNJ905503F, Lot Number 22LBF425 ;
DYNJ905503F, Lot Number 23BBN903 ;
DYNJ905503F, Lot Number 23CBL450 ;
DYNJ905503F, Lot Number 23CBW776 ;
DYNJ905503F, Lot Number 23FBC209 ;
DYNJ905503F, Lot Number 23IBU343 ;
DYNJ905503F, Lot Number 23JBP494 ;
DYNJ905503F, Lot Number 23KBH749 ;
DYNJ905503F, Lot Number 23KBQ236 ;
DYNJ905503F, Lot Number 23LBR048 ;
DYNJ905503F, Lot Number 24BBH974 ;
DYNJ910129 , Lot Number 24AMF749 ;
DYNJAA10379, Lot Number 19HBV537 ;
DYNJAA6572 , Lot Number 20FBL919 ;
DYNJAASAMPLE, Lot Number 21IBA814;
DYNJAASAMPLE, Lot Number 21IBA815;
DYNJAASAMPLE, Lot Number 21HBE107;
DYNJAASAMPLE, Lot Number 21FBU433;
DYNJAASAMPLE, Lot Number 21EBM583;
DYNJAASAMPLE , Lot Number 19HBP877 ;
DYNJAASAMPLE , Lot Number 19KBF202 ;
DYNJRA0376A, Lot Number 21JBA836 ;
DYNJRA0376A, Lot Number 21KBI074 ;
DYNJRA0376A, Lot Number 21KBP359 ;
DYNJRA0376A, Lot Number 21KBU250 ;
DYNJRA0376A, Lot Number 22ABU499 ;
DYNJRA0376A, Lot Number 19ABT679 ;
DYNJRA0376A, Lot Number 19BBH464 ;
DYNJRA0376A, Lot Number 19CBM742 ;
DYNJRA0376A, Lot Number 19DBV170 ;
DYNJRA0376A, Lot Number 19EBC310 ;
DYNJRA0376A, Lot Number 19EBZ313 ;
DYNJRA0376A, Lot Number 19FBP671 ;
DYNJRA0376A, Lot Number 22JBU142 ;
DYNJRA0376A, Lot Number 19IBN472 ;
DYNJRA0376A, Lot Number 19JBN388 ;
DYNJRA0376A, Lot Number 23ABN343 ;
DYNJRA0376A, Lot Number 19WBB195 ;
DYNJRA0376A, Lot Number 23DBN153 ;
DYNJRA0376A, Lot Number 20ABP822 ;
DYNJRA0376A, Lot Number 20BBG986 ;
DYNJRA0376A, Lot Number 23FBJ727 ;
DYNJRA0376A, Lot Number 20FBS238 ;
DYNJRA0376A, Lot Number 23JBT431 ;
DYNJRA0376A, Lot Number 20JBB325 ;
DYNJRA0376A, Lot Number 20JBS327 ;
DYNJRA0376A, Lot Number 21CBC005 ;
DYNJRA0376A, Lot Number 21FBA847 ;
DYNJRA0376A, Lot Number 21FBF515 ;
DYNJRA0424A, Lot Number 19BLA192 ;
DYNJRA0424A, Lot Number 19ELA369 ;
DYNJRA0424A, Lot Number 19ILA097 ;
DYNJRA0424A, Lot Number 19ILA581 ;
DYNJRA0424A, Lot Number 20BLA165 ;
DYNJRA0424A, Lot Number 20DLA320 ;
DYNJRA0424A, Lot Number 20ILA236 ;
DYNJRA0424A, Lot Number 20ILA689 ;
DYNJRA0424A, Lot Number 20JLA266 ;
DYNJRA0767 , Lot Number 19ABB420 ;
DYNJRA0767 , Lot Number 19ABB495 ;
DYNJRA0767 , Lot Number 19BBB590 ;
DYNJRA0767 , Lot Number 19EBV290 ;
DYNJRA0767A, Lot Number 19GLA471 ;
DYNJRA0767A, Lot Number 19JLA131 ;
DYNJRA0767A, Lot Number 19KLA574 ;
DYNJRA0767A, Lot Number 20ALA762 ;
DYNJRA0767B, Lot Number 20BLA575 ;
DYNJRA0767B, Lot Number 20DLA137 ;
DYNJRA0767B, Lot Number 20GLA730 ;
DYNJRA0767B, Lot Number 20ILA116 ;
DYNJRA0767B, Lot Number 20KLA503 ;
DYNJRA0767B, Lot Number 20LLA193 ;
DYNJRA0767B, Lot Number 21ALA504 ;
DYNJRA0767B, Lot Number 21DLA280 ;
DYNJRA0767B, Lot Number 21ELA804 ;
DYNJRA0767B, Lot Number 21GLA351 ;
DYNJRA0779A, Lot Number 19BBE138 ;
DYNJRA0887A, Lot Number 21HBJ813 ;
DYNJRA0887A, Lot Number 21KBF202 ;
DYNJRA0887A, Lot Number 22ABL039 ;
DYNJRA0887A, Lot Number 19ABB764 ;
DYNJRA0887A, Lot Number 22BBO561 ;
DYNJRA0887A, Lot Number 22DBL385 ;
DYNJRA0887A, Lot Number 22DBL387 ;
DYNJRA0887A, Lot Number 19DBQ652 ;
DYNJRA0887A, Lot Number 22EBN188 ;
DYNJRA0887A, Lot Number 19EBM156 ;
DYNJRA0887A, Lot Number 22FBN499 ;
DYNJRA0887A, Lot Number 19FBG819 ;
DYNJRA0887A, Lot Number 19GBN973 ;
DYNJRA0887A, Lot Number 20ABG794 ;
DYNJRA0887A, Lot Number 23EBA855 ;
DYNJRA0887A, Lot Number 20CBA118 ;
DYNJRA0887A, Lot Number 20CBT347 ;
DYNJRA0887A, Lot Number 20CBZ291 ;
DYNJRA0887A, Lot Number 23HBX546 ;
DYNJRA0887A, Lot Number 20EBP521 ;
DYNJRA0887A, Lot Number 23IBM658 ;
DYNJRA0887A, Lot Number 20GBA834 ;
DYNJRA0887A, Lot Number 23JBY667 ;
DYNJRA0887A, Lot Number 23LBA050 ;
DYNJRA0887A, Lot Number 20KBS435 ;
DYNJRA0887A, Lot Number 20WBA633 ;
DYNJRA0887A, Lot Number 20LBU607 ;
DYNJRA0909 , Lot Number 21IBM432 ;
DYNJRA0909 , Lot Number 21JBB919 ;
DYNJRA0909 , Lot Number 21JBJ840 ;
DYNJRA0909 , Lot Number 21LBI511 ;
DYNJRA0909 , Lot Number 22BBK053 ;
DYNJRA0909 , Lot Number 19ABK394 ;
DYNJRA0909 , Lot Number 22CBV876 ;
DYNJRA0909 , Lot Number 19DBH758 ;
DYNJRA0909 , Lot Number 22EBB982 ;
DYNJRA0909 , Lot Number 19EBX778 ;
DYNJRA0909 , Lot Number 19SBA717 ;
DYNJRA0909 , Lot Number 19IBH329 ;
DYNJRA0909 , Lot Number 22KBK484 ;
DYNJRA0909 , Lot Number 22LBH510 ;
DYNJRA0909 , Lot Number 19KBD605 ;
DYNJRA0909 , Lot Number 23BBS655 ;
DYNJRA0909 , Lot Number 19KBX403 ;
DYNJRA0909 , Lot Number 23DBC885 ;
DYNJRA0909 , Lot Number 20BBQ111 ;
DYNJRA0909 , Lot Number 20BBR726 ;
DYNJRA0909 , Lot Number 23FBK613 ;
DYNJRA0909 , Lot Number 23GBT449 ;
DYNJRA0909 , Lot Number 23IBL594 ;
DYNJRA0909 , Lot Number 20FBN090 ;
DYNJRA0909 , Lot Number 23KBC242 ;
DYNJRA0909 , Lot Number 20HBN921 ;
DYNJRA0909 , Lot Number 23LBU798 ;
DYNJRA0909 , Lot Number 20JBS343 ;
DYNJRA0909 , Lot Number 20LBP468 ;
DYNJRA0909 , Lot Number 21OBA552 ;
DYNJRA0909 , Lot Number 21FBD258 ;
DYNJRA0955A, Lot Number 19ADB360 ;
DYNJRA0955A, Lot Number 19EDB618 ;
DYNJRA0955A, Lot Number 19HDA472 ;
DYNJRA0955A, Lot Number 20ADC459 ;
DYNJRA0955A, Lot Number 20CDB147 ;
DYNJRA0955A, Lot Number 20FDC321 ;
DYNJRA0955A, Lot Number 20HDC485 ;
DYNJRA0955A, Lot Number 20JDA615 ;
DYNJRA0955A, Lot Number 20LDA004 ;
DYNJRA0955A, Lot Number 20LDB451 ;
DYNJRA0955A, Lot Number 21ADA927 ;
DYNJRA0955A, Lot Number 21EDB811 ;
DYNJRA0955A, Lot Number 21IDB370 ;
DYNJRA0955A, Lot Number 21JDA420 ;
DYNJRA0955A, Lot Number 21KDB440 ;
DYNJRA0955A, Lot Number 21LDA933 ;
DYNJRA0955A, Lot Number 22BDB266 ;
DYNJRA0955A, Lot Number 22EDB897 ;
DYNJRA0955A, Lot Number 22JDA402 ;
DYNJRA0955A, Lot Number 22LDB425 ;
DYNJRA0955A, Lot Number 23BDA481 ;
DYNJRA0955A, Lot Number 23EDA343 ;
DYNJRA0955A, Lot Number 23IDB489 ;
DYNJRA0955A, Lot Number 23LDA640 ;
DYNJRA0955A, Lot Number 24ADC151 ;
DYNJRA0955A, Lot Number 24CDA833 ;
DYNJRA0968 , Lot Number 21HBF288 ;
DYNJRA0968 , Lot Number 21JBT830 ;
DYNJRA0968 , Lot Number 21LBY093 ;
DYNJRA0968 , Lot Number 19BBE830 ;
DYNJRA0968 , Lot Number 22OBI659 ;
DYNJRA0968 , Lot Number 19DBR761 ;
DYNJRA0968 , Lot Number 22EBT662 ;
DYNJRA0968 , Lot Number 19EBR863 ;
DYNJRA0968 , Lot Number 19FBV435 ;
DYNJRA0968 , Lot Number 22JBL305 ;
DYNJRA0968 , Lot Number 19IBU668 ;
DYNJRA0968 , Lot Number 19KBO051 ;
DYNJRA0968 , Lot Number 20BBQ119 ;
DYNJRA0968 , Lot Number 20EBA140 ;
DYNJRA0968 , Lot Number 20HBV152 ;
DYNJRA1119 , Lot Number 19ABB888 ;
DYNJRA1119 , Lot Number 19ABF794 ;
DYNJRA1119 , Lot Number 19DBS320 ;
DYNJRA1119 , Lot Number 19FBU183 ;
DYNJRA1119 , Lot Number 19JBJ900 ;
DYNJRA1119 , Lot Number 19LBI573 ;
DYNJRA1119 , Lot Number 20CBO496 ;
DYNJRA1119 , Lot Number 20EBA135 ;
DYNJRA1119 , Lot Number 20FBC818 ;
DYNJRA1119 , Lot Number 20KBC430 ;
DYNJRA1119 , Lot Number 20KBS507 ;
DYNJRA1119 , Lot Number 20WBA649 ;
DYNJRA1119 , Lot Number 20XBA718 ;
DYNJRA1119A, Lot Number 21LBM005 ;
DYNJRA1119A, Lot Number 22OBE977 ;
DYNJRA1119A, Lot Number 22OBG228 ;
DYNJRA1119A, Lot Number 22OBH490 ;
DYNJRA1119A, Lot Number 22DBL388 ;
DYNJRA1119A, Lot Number 22DBL389 ;
DYNJRA1119A, Lot Number 22DBL390 ;
DYNJRA1119A, Lot Number 22HBM810 ;
DYNJRA1119A, Lot Number 22IBT110 ;
DYNJRA1355 , Lot Number 19DDB243 ;
DYNJRA1355 , Lot Number 20EDB062 ;
DYNJRA1355 , Lot Number 20KDA418 ;
DYNJRA1355 , Lot Number 21HDA638 ;
DYNJRA1355 , Lot Number 21KDC271 ;
DYNJRA1355 , Lot Number 22BDB953 ;
DYNJRA1355 , Lot Number 22CDA294 ;
DYNJRA1355A, Lot Number 23EBS294 ;
DYNJRA1355A, Lot Number 23FBB136 ;
DYNJRA1355A, Lot Number 23LBU793 ;
DYNJRA1577A, Lot Number 20BLA161 ;
DYNJRA1577A, Lot Number 20GLA679 ;
DYNJRA1577A, Lot Number 20HLA024 ;
DYNJRA1577A, Lot Number 21DLA789 ;
DYNJRA1577A, Lot Number 21HLA237 ;
DYNJRA1577A, Lot Number 21JLA880 ;
DYNJRA1577A, Lot Number 22ALA178 ;
DYNJRA1577A, Lot Number 22FLB148 ;
DYNJRA1577A, Lot Number 22JLA138 ;
DYNJRA1577A, Lot Number 22KLA017 ;
DYNJRA1659 , Lot Number 20GBL316 ;
DYNJRA1659A, Lot Number 21HBL723 ;
DYNJRA1659A, Lot Number 21KBD763 ;
DYNJRA1659A, Lot Number 22ABH121 ;
DYNJRA1659A, Lot Number 22BBH682 ;
DYNJRA1659A, Lot Number 22EBO710 ;
DYNJRA1659A, Lot Number 20JBK938 ;
DYNJRA1659A, Lot Number 20KBS464 ;
DYNJRA1659A, Lot Number 20KBX281 ;
DYNJRA1659A, Lot Number 20XBB194 ;
DYNJRA1659A, Lot Number 21DBO798 ;
DYNJRA1659A, Lot Number 21DBU473 ;
DYNJRA1659A, Lot Number 22GMG057 ;
DYNJRA1659A, Lot Number 22JMG120 ;
DYNJRA1757 , Lot Number 21GBH846 ;
DYNJRA1757 , Lot Number 21HBI684 ;
DYNJRA1757 , Lot Number 21HBL719 ;
DYNJRA1757 , Lot Number 21JBB912 ;
DYNJRA1757 , Lot Number 21JBX538 ;
DYNJRA1757 , Lot Number 21LBP546 ;
DYNJRA1757 , Lot Number 22ABN356 ;
DYNJRA1757 , Lot Number 22ABU537 ;
DYNJRA1757 , Lot Number 22EBI319 ;
DYNJRA1757 , Lot Number 22GBD823 ;
DYNJRA1757 , Lot Number 22HBL721 ;
DYNJRA1757 , Lot Number 22LBC462 ;
DYNJRA1757 , Lot Number 23ABF387 ;
DYNJRA1757 , Lot Number 23BBC744 ;
DYNJRA1757 , Lot Number 23CBR306 ;
DYNJRA1757 , Lot Number 23EBE047 ;
DYNJRA1757 , Lot Number 23GBM489 ;
DYNJRA1757 , Lot Number 23IBW129 ;
DYNJRA1757 , Lot Number 23KBX075 ;
DYNJRA1757 , Lot Number 21CBD668 ;
DYNJRA1757 , Lot Number 21EBI263 ;
DYNJRA1757 , Lot Number 21FBC480 ;
DYNJRA1899 , Lot Number 22BBB022 ;
DYNJRA1899 , Lot Number 22FBN862 ;
DYNJRA1899 , Lot Number 23ABG680 ;
DYNJRA1899 , Lot Number 23CBR650 ;
DYNJRA1899 , Lot Number 23EBX287 ;
DYNJRA1899 , Lot Number 23KBW986 ;
DYNJRA1934 , Lot Number 22FBG297 ;
DYNJRA1934 , Lot Number 22JBO101 ;
DYNJRA1934 , Lot Number 23GBP086 ;
DYNJRA1934 , Lot Number 23IBM814 ;
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Recalling Firm/
Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
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| For Additional Information Contact | Karin Johnson
886-359-1704 |
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Manufacturer Reason
for Recall | 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. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | Medline Industries LP issued a recall notice to its consignees on 04/08/2024 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request these syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers. The firm issued a second recall notice (an expansion) on 05/02/2024 using the same methods. |
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| Distribution | Worldwide distribution. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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