| | Class 2 Device Recall Medline |  |
| Date Initiated by Firm | April 08, 2024 |
|---|
| Date Posted | September 06, 2024 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-3004-2024 |
|---|
| Recall Event ID |
94583 |
| Product Classification |
Tray, biopsy, without biopsy instruments - Product Code FCH
|
| Product | Medline Convenience kits labeled as:
1) FETOSCOPY CDS-LF, Pack Number CDS840215O ;
2) BONE RETRIEVAL PART A , Pack Number CDS981237F ;
3) BASIC BIOPSY TRAY , Pack Number DYNDA1217A ;
4) ONCOLOGY PORT ACCESS TRAY , Pack Number DYNDC2239;
5) US BREAST BIOPSY TRAY, Pack Number DYNDH1187A;
6) BONE MARROW TRAY - TUBE HLDR, Pack Number DYNDH1286A;
7) BONE MARROW TRAY - TUBE HLDR, Pack Number DYNDH1286AH;
8) PACK,BREAST BIOPSY, Pack Number DYNDL1498;
9) BONE MARROW PACK, Pack Number DYNJ0628436I ;
10) SH STEREOTACTIC BIOPSY PK-LF, Pack Number DYNJ0660035K;
11) SH STEREOTACTIC BIOPSY PK-LF, Pack Number DYNJ0660035KH;
12) OPP MINOR PACK-LF , Pack Number DYNJ0706869I ;
13) OPP MINOR PACK-LF , Pack Number DYNJ0706869IH;
14) BIOPSY DRAPE PACK , Pack Number DYNJ20953F ;
15) STEREOTACTIC TRAY , Pack Number DYNJ28856D ;
16) BIOPSY TRAY , Pack Number DYNJ31585C ;
17) BONE MARROW KIT PK, Pack Number DYNJ37526;
18) CT BIOPSY PACK-LF , Pack Number DYNJ38414B ;
19) CUSTOM BONE CEMENT TRAY-LF, Pack Number DYNJ42702D ;
20) LIVER TRANSPLANT PACK , Pack Number DYNJ43493A ;
21) BIOPSY TRAY , Pack Number DYNJ49368;
22) BONE MARROW HARVEST PACK, Pack Number DYNJ50740A ;
23) HINKAMP ACCESSORY PACK, Pack Number DYNJ66550;
24) HINKAMP ACCESSORY PACK, Pack Number DYNJ66550A ;
25) NDN CUSTOM BONE RECOVERY, Pack Number DYNJ903942D;
26) MODULE BREAST BIOPSY, Pack Number DYNJ904158B;
27) PACK,FETOSCOPY, Pack Number DYNJ906905B;
28) MINOR/BREAST BIOPSY-LF, Pack Number DYNJS3035;
29) BREAST BIOPSY-LF, Pack Number DYNJT1911D ;
30) BIOPSY TRAY , Pack Number SPEC0150 ;
31) BIOPSY TRAY W/O LIDOCAINE , Pack Number SPEC0196B;
32) STEREOTACTIC BIOPSY TRAY, Pack Number SPEC0279 |
|---|
| Code Information |
CDS840215O , Lot Number 21HBJ135 ;
CDS840215O , Lot Number 21JBS174 ;
CDS840215O , Lot Number 22ABB090 ;
CDS840215O , Lot Number 22ABS124 ;
CDS840215O , Lot Number 22EBA066 ;
CDS840215O , Lot Number 22GBQ007 ;
CDS840215O , Lot Number 22GBQ009 ;
CDS840215O , Lot Number 22HBU942 ;
CDS840215O , Lot Number 23ABD369 ;
CDS840215O , Lot Number 23CBO683 ;
CDS840215O , Lot Number 23FBT988 ;
CDS840215O , Lot Number 23GBI919 ;
CDS840215O , Lot Number 23JBK910 ;
CDS840215O , Lot Number 24ABE598 ;
CDS840215O , Lot Number 20LBA006 ;
CDS840215O , Lot Number 21ABQ774 ;
CDS840215O , Lot Number 21ABR763 ;
CDS840215O , Lot Number 21ABT392 ;
CDS840215O , Lot Number 21CBM879 ;
CDS840215O , Lot Number 21CBY329 ;
CDS840215O , Lot Number 21DBP547 ;
CDS981237F , Lot Number 19BBH974 ;
CDS981237F , Lot Number 19DBZ760 ;
CDS981237F , Lot Number 19GBG896 ;
CDS981237F , Lot Number 19GBR697 ;
CDS981237F , Lot Number 19IBK312 ;
CDS981237F , Lot Number 19JBS472 ;
CDS981237F , Lot Number 19VBE313 ;
CDS981237F , Lot Number 19LBQ636 ;
CDS981237F , Lot Number 20BBS514 ;
DYNDA1217A , Lot Number 21JBQ356 ;
DYNDC2239, Lot Number 21JBL152 ;
DYNDH1187A, Lot Number 22HMH338;
DYNDH1187A, Lot Number 22FMA363;
DYNDH1187A, Lot Number 22EBC538;
DYNDH1187A, Lot Number 22OBA249;
DYNDH1187A, Lot Number 22BBZ459;
DYNDH1187A, Lot Number 22HMH338;
DYNDH1187A, Lot Number 22FMA363;
DYNDH1187A, Lot Number 22EBC538;
DYNDH1187A, Lot Number 22OBA249;
DYNDH1187A, Lot Number 22BBZ459;
DYNDH1286A, Lot Number 23FMA562;
DYNDH1286A, Lot Number 23DME451;
DYNDH1286A, Lot Number 23AMH934;
DYNDH1286A , Lot Number 23JMC410 ;
DYNDH1286AH, Lot Number 23FMA562;
DYNDH1286AH, Lot Number 23DME451;
DYNDH1286AH, Lot Number 23AMH934;
DYNDH1286AH, Lot Number 23JMC410 ;
DYNDL1498, Lot Number 21JBM328 ;
DYNJ0628436I , Lot Number 20CDA324 ;
DYNJ0628436I , Lot Number 20DDB806 ;
DYNJ0628436I , Lot Number 20FDA658 ;
DYNJ0628436I , Lot Number 20IDB329 ;
DYNJ0628436I , Lot Number 20LDC229 ;
DYNJ0628436I , Lot Number 21ADA277 ;
DYNJ0628436I , Lot Number 21DDB241 ;
DYNJ0628436I , Lot Number 21IDA223 ;
DYNJ0628436I , Lot Number 21IDB517 ;
DYNJ0628436I , Lot Number 21JDA063 ;
DYNJ0628436I , Lot Number 21JDA834 ;
DYNJ0628436I , Lot Number 21JDB718 ;
DYNJ0660035K, Lot Number 24ALA341;
DYNJ0660035K, Lot Number 23GLA731;
DYNJ0660035K, Lot Number 23DLA072;
DYNJ0660035KH, Lot Number 24ALA341;
DYNJ0660035KH, Lot Number 23GLA731;
DYNJ0660035KH, Lot Number 23DLA072;
DYNJ0706869I , Lot Number 20JMC336 ;
DYNJ0706869I , Lot Number 20LMD691 ;
DYNJ0706869I , Lot Number 21DME377 ;
DYNJ0706869I , Lot Number 21FMD242 ;
DYNJ0706869I , Lot Number 21LMC086 ;
DYNJ0706869I , Lot Number 22AMC817 ;
DYNJ0706869I , Lot Number 22DME371 ;
DYNJ0706869I , Lot Number 22EMD666 ;
DYNJ0706869I , Lot Number 22FMA242 ;
DYNJ0706869I , Lot Number 22GMD755 ;
DYNJ0706869I , Lot Number 22IMB513 ;
DYNJ0706869I , Lot Number 22IMB656 ;
DYNJ0706869I , Lot Number 22LMA106 ;
DYNJ0706869I , Lot Number 23BMG720 ;
DYNJ0706869I , Lot Number 23DMB102 ;
DYNJ0706869I , Lot Number 23EMI240 ;
DYNJ0706869I , Lot Number 23FMH902 ;
DYNJ0706869I , Lot Number 23HMC291 ;
DYNJ0706869I , Lot Number 23IMG874 ;
DYNJ0706869I , Lot Number 23JMG263 ;
DYNJ0706869I , Lot Number 23KMI951 ;
DYNJ0706869I , Lot Number 19AKC096 ;
DYNJ0706869I , Lot Number 19BKC989 ;
DYNJ0706869I , Lot Number 19DKA116 ;
DYNJ0706869I , Lot Number 19EKA641 ;
DYNJ0706869I , Lot Number 19FKB385 ;
DYNJ0706869I , Lot Number 19HKA718 ;
DYNJ0706869I , Lot Number 19IKA169 ;
DYNJ0706869I , Lot Number 19KKC060 ;
DYNJ0706869I , Lot Number 20BKB668 ;
DYNJ0706869I , Lot Number 20EKA822 ;
DYNJ0706869I , Lot Number 20HKA809 ;
DYNJ0706869IH, Lot Number 21DME377 ;
DYNJ0706869IH, Lot Number 21FMD242 ;
DYNJ0706869IH, Lot Number 19AKC096 ;
DYNJ0706869IH, Lot Number 19BKC989 ;
DYNJ0706869IH, Lot Number 21LMC086 ;
DYNJ0706869IH, Lot Number 19DKA116 ;
DYNJ0706869IH, Lot Number 19EKA641 ;
DYNJ0706869IH, Lot Number 19FKB385 ;
DYNJ0706869IH, Lot Number 22AMC817 ;
DYNJ0706869IH, Lot Number 19HKA718 ;
DYNJ0706869IH, Lot Number 19IKA169 ;
DYNJ0706869IH, Lot Number 19KKC060 ;
DYNJ0706869IH, Lot Number 22DME371 ;
DYNJ0706869IH, Lot Number 22EMD666 ;
DYNJ0706869IH, Lot Number 22FMA242 ;
DYNJ0706869IH, Lot Number 22GMD755 ;
DYNJ0706869IH, Lot Number 22IMB513 ;
DYNJ0706869IH, Lot Number 22IMB656 ;
DYNJ0706869IH, Lot Number 22LMA106 ;
DYNJ0706869IH, Lot Number 23BMG720 ;
DYNJ0706869IH, Lot Number 23DMB102 ;
DYNJ0706869IH, Lot Number 23EMI240 ;
DYNJ0706869IH, Lot Number 23FMH902 ;
DYNJ0706869IH, Lot Number 23HMC291 ;
DYNJ0706869IH, Lot Number 23IMG874 ;
DYNJ0706869IH, Lot Number 23JMG263 ;
DYNJ0706869IH, Lot Number 23KMI951 ;
DYNJ20953F , Lot Number 21ELA134 ;
DYNJ20953F , Lot Number 21GLA448 ;
DYNJ20953F , Lot Number 21HLA653 ;
DYNJ20953F , Lot Number 21JLA115 ;
DYNJ20953F , Lot Number 21LLA043 ;
DYNJ20953F , Lot Number 22ALA485 ;
DYNJ20953F , Lot Number 22CLA673 ;
DYNJ20953F , Lot Number 22DLA696 ;
DYNJ20953F , Lot Number 19AKC194 ;
DYNJ20953F , Lot Number 19CKB503 ;
DYNJ20953F , Lot Number 19EKB212 ;
DYNJ20953F , Lot Number 19FKC476 ;
DYNJ20953F , Lot Number 19HKA346 ;
DYNJ20953F , Lot Number 19IKB981 ;
DYNJ20953F , Lot Number 19JKA937 ;
DYNJ20953F , Lot Number 19KKB073 ;
DYNJ20953F , Lot Number 20AKB265 ;
DYNJ20953F , Lot Number 20DKA525 ;
DYNJ20953F , Lot Number 20EKA867 ;
DYNJ20953F , Lot Number 20FKB636 ;
DYNJ20953F , Lot Number 20HKB650 ;
DYNJ20953F , Lot Number 20JKB301 ;
DYNJ20953F , Lot Number 20KKA781 ;
DYNJ20953F , Lot Number 21AKA562 ;
DYNJ20953F , Lot Number 21DKA141 ;
DYNJ28856D , Lot Number 19ALA181 ;
DYNJ28856D , Lot Number 19CLA313 ;
DYNJ28856D , Lot Number 19DLA642 ;
DYNJ28856D , Lot Number 19JLA386 ;
DYNJ28856D , Lot Number 19LLA006 ;
DYNJ28856D , Lot Number 20ALA170 ;
DYNJ28856D , Lot Number 20CLA553 ;
DYNJ28856D , Lot Number 20DLA268 ;
DYNJ28856D , Lot Number 21ALA407 ;
DYNJ28856D , Lot Number 21BLA034 ;
DYNJ28856D , Lot Number 21CLA419 ;
DYNJ31585C , Lot Number 21ELA814 ;
DYNJ31585C , Lot Number 21JLA477 ;
DYNJ31585C , Lot Number 22BLA693 ;
DYNJ31585C , Lot Number 22ILA016 ;
DYNJ31585C , Lot Number 22KLA729 ;
DYNJ31585C , Lot Number 24ALA690 ;
DYNJ31585C , Lot Number 19CKD774 ;
DYNJ31585C , Lot Number 19HKC979 ;
DYNJ31585C , Lot Number 20BKB640 ;
DYNJ31585C , Lot Number 20KKA827 ;
DYNJ37526, Lot Number 19CDA532 ;
DYNJ37526, Lot Number 19FDC312 ;
DYNJ37526, Lot Number 20DDA550 ;
DYNJ37526, Lot Number 21BDA027 ;
DYNJ37526, Lot Number 22BDB609 ;
DYNJ37526, Lot Number 22BDC211 ;
DYNJ37526, Lot Number 24BDB879 ;
DYNJ38414B , Lot Number 21DLA560 ;
DYNJ38414B , Lot Number 21ELA636 ;
DYNJ38414B , Lot Number 21GLA068 ;
DYNJ38414B , Lot Number 21HLA711 ;
DYNJ38414B , Lot Number 21JLA068 ;
DYNJ38414B , Lot Number 21LLA898 ;
DYNJ38414B , Lot Number 22CLA518 ;
DYNJ38414B , Lot Number 22ELA196 ;
DYNJ38414B , Lot Number 22FLA933 ;
DYNJ38414B , Lot Number 22GLA926 ;
DYNJ38414B , Lot Number 22HLB262 ;
DYNJ38414B , Lot Number 22JLA623 ;
DYNJ38414B , Lot Number 23ALA320 ;
DYNJ38414B , Lot Number 23DLA256 ;
DYNJ38414B , Lot Number 23DLB088 ;
DYNJ38414B , Lot Number 23ELA575 ;
DYNJ38414B , Lot Number 23FLB074 ;
DYNJ38414B , Lot Number 23HLA831 ;
DYNJ38414B , Lot Number 23JLA563 ;
DYNJ38414B , Lot Number 23KLA596 ;
DYNJ38414B , Lot Number 24ALA832 ;
DYNJ38414B , Lot Number 19AKC074 ;
DYNJ38414B , Lot Number 19CKC932 ;
DYNJ38414B , Lot Number 19EKB260 ;
DYNJ38414B , Lot Number 19EKD084 ;
DYNJ38414B , Lot Number 19GKA529 ;
DYNJ38414B , Lot Number 19GKC252 ;
DYNJ38414B , Lot Number 19HKC005 ;
DYNJ38414B , Lot Number 19JKA355 ;
DYNJ38414B , Lot Number 19LKB738 ;
DYNJ38414B , Lot Number 20AKB834 ;
DYNJ38414B , Lot Number 20BKB556 ;
DYNJ38414B , Lot Number 20FKA065 ;
DYNJ38414B , Lot Number 20FKB988 ;
DYNJ38414B , Lot Number 20JKB019 ;
DYNJ38414B , Lot Number 20KKA574 ;
DYNJ38414B , Lot Number 21AKA080 ;
DYNJ42702D , Lot Number 19ADA279 ;
DYNJ42702D , Lot Number 19BDA365 ;
DYNJ42702D , Lot Number 19BDD481 ;
DYNJ42702D , Lot Number 19EDC319 ;
DYNJ42702D , Lot Number 19FDB945 ;
DYNJ42702D , Lot Number 19IDA212 ;
DYNJ42702D , Lot Number 19JDA646 ;
DYNJ42702D , Lot Number 19JDC432 ;
DYNJ42702D , Lot Number 20BDA399 ;
DYNJ42702D , Lot Number 20DDA234 ;
DYNJ42702D , Lot Number 20DDA364 ;
DYNJ42702D , Lot Number 20DDB590 ;
DYNJ42702D , Lot Number 20IDC706 ;
DYNJ42702D , Lot Number 20LDB764 ;
DYNJ42702D , Lot Number 21ADA332 ;
DYNJ42702D , Lot Number 21BDB947 ;
DYNJ42702D , Lot Number 21EDB182 ;
DYNJ42702D , Lot Number 21HDB001 ;
DYNJ42702D , Lot Number 21IDA042 ;
DYNJ42702D , Lot Number 22BDB745 ;
DYNJ42702D , Lot Number 22CDC225 ;
DYNJ42702D , Lot Number 22FDB912 ;
DYNJ42702D , Lot Number 22KDB221 ;
DYNJ42702D , Lot Number 23BDB853 ;
DYNJ42702D , Lot Number 23DDA540 ;
DYNJ42702D , Lot Number 23FDA089 ;
DYNJ42702D , Lot Number 23GDA365 ;
DYNJ42702D , Lot Number 23JDC551 ;
DYNJ42702D , Lot Number 23LDC015 ;
DYNJ42702D , Lot Number 24BDB395 ;
DYNJ43493A , Lot Number 19ABM222 ;
DYNJ49368, Lot Number 21GBU401 ;
DYNJ49368, Lot Number 21IBJ806 ;
DYNJ49368, Lot Number 21KBM934 ;
DYNJ49368, Lot Number 21LBW773 ;
DYNJ49368, Lot Number 22CBV642 ;
DYNJ49368, Lot Number 19CBA603 ;
DYNJ49368, Lot Number 22DBP231 ;
DYNJ49368, Lot Number 19PBC340 ;
DYNJ49368, Lot Number 22FBD715 ;
DYNJ49368, Lot Number 19FBH514 ;
DYNJ49368, Lot Number 22GBV458 ;
DYNJ49368, Lot Number 19GBN956 ;
DYNJ49368, Lot Number 22JBQ138 ;
DYNJ49368, Lot Number 22KBJ578 ;
DYNJ49368, Lot Number 22LBQ363 ;
DYNJ49368, Lot Number 19VBE690 ;
DYNJ49368, Lot Number 23ABP599 ;
DYNJ49368, Lot Number 23CBD529 ;
DYNJ49368, Lot Number 23CBR420 ;
DYNJ49368, Lot Number 23DBM035 ;
DYNJ49368, Lot Number 23EBL513 ;
DYNJ49368, Lot Number 20CBH411 ;
DYNJ49368, Lot Number 23GBH227 ;
DYNJ49368, Lot Number 20DBJ728 ;
DYNJ49368, Lot Number 23IBC420 ;
DYNJ49368, Lot Number 20FBU558 ;
DYNJ49368, Lot Number 23JBX049 ;
DYNJ49368, Lot Number 20LBL396 ;
DYNJ49368, Lot Number 21ABD738 ;
DYNJ49368, Lot Number 21CBS175 ;
DYNJ49368, Lot Number 21EBL511 ;
DYNJ50740A , Lot Number 22ABE281 ;
DYNJ50740A , Lot Number 22DBS385 ;
DYNJ50740A , Lot Number 19EBL176 ;
DYNJ50740A , Lot Number 22FBO930 ;
DYNJ50740A , Lot Number 22GBT984 ;
DYNJ50740A , Lot Number 19KBY078 ;
DYNJ50740A , Lot Number 19LBI960 ;
DYNJ50740A , Lot Number 20WBC156 ;
DYNJ66550, Lot Number 20FLA484 ;
DYNJ66550, Lot Number 20GLA274 ;
DYNJ66550, Lot Number 20GLA442 ;
DYNJ66550, Lot Number 20ILA192 ;
DYNJ66550A , Lot Number 20JLA316 ;
DYNJ66550A , Lot Number 20KLA061 ;
DYNJ66550A , Lot Number 20KLA251 ;
DYNJ66550A , Lot Number 21BLA448 ;
DYNJ66550A , Lot Number 21HLA027 ;
DYNJ66550A , Lot Number 21ILA340 ;
DYNJ66550A , Lot Number 21KLB095 ;
DYNJ66550A , Lot Number 22BLB208 ;
DYNJ66550A , Lot Number 22CLB050 ;
DYNJ66550A , Lot Number 22DLA315 ;
DYNJ903942D, Lot Number 21GBO392 ;
DYNJ903942D, Lot Number 21JBM620 ;
DYNJ903942D, Lot Number 21KBS603 ;
DYNJ903942D, Lot Number 21KBS604 ;
DYNJ903942D, Lot Number 22ABD050 ;
DYNJ903942D, Lot Number 22MBA673 ;
DYNJ903942D, Lot Number 22BBS845 ;
DYNJ903942D, Lot Number 22DBG084 ;
DYNJ903942D, Lot Number 22FBM577 ;
DYNJ903942D, Lot Number 22FBM578 ;
DYNJ903942D, Lot Number 22FBM589 ;
DYNJ903942D, Lot Number 22IBG104 ;
DYNJ903942D, Lot Number 22JBP648 ;
DYNJ903942D, Lot Number 22JBP649 ;
DYNJ903942D, Lot Number 22KBN933 ;
DYNJ903942D, Lot Number 23ABE488 ;
DYNJ903942D, Lot Number 23ABO256 ;
DYNJ903942D, Lot Number 23ABP894 ;
DYNJ903942D, Lot Number 23ABS767 ;
DYNJ903942D, Lot Number 23CBI126 ;
DYNJ903942D, Lot Number 23CBQ109 ;
DYNJ903942D, Lot Number 23DBM169 ;
DYNJ903942D, Lot Number 23DBR799 ;
DYNJ903942D, Lot Number 23EBV305 ;
DYNJ903942D, Lot Number 23EBX153 ;
DYNJ903942D, Lot Number 23FBE572 ;
DYNJ903942D, Lot Number 23GBQ051 ;
DYNJ903942D, Lot Number 23HBY686 ;
DYNJ903942D, Lot Number 23JBD675 ;
DYNJ903942D, Lot Number 23KBM793 ;
DYNJ903942D, Lot Number 23LBP048 ;
DYNJ903942D, Lot Number 23LBP853 ;
DYNJ903942D, Lot Number 24ABE247 ;
DYNJ903942D, Lot Number 24ABH578 ;
DYNJ903942D, Lot Number 19GKC678 ;
DYNJ903942D, Lot Number 19IKB896 ;
DYNJ903942D, Lot Number 19JKB279 ;
DYNJ903942D, Lot Number 19LKA016 ;
DYNJ903942D, Lot Number 20AKA689 ;
DYNJ903942D, Lot Number 20BKB196 ;
DYNJ903942D, Lot Number 20CKA097 ;
DYNJ903942D, Lot Number 20CKA804 ;
DYNJ903942D, Lot Number 20EKB749 ;
DYNJ903942D, Lot Number 20GKA184 ;
DYNJ903942D, Lot Number 20GKB636 ;
DYNJ903942D, Lot Number 21AKA242 ;
DYNJ903942D, Lot Number 21BKA494 ;
DYNJ903942D, Lot Number 21CKA499 ;
DYNJ903942D, Lot Number 21CKB142 ;
DYNJ903942D, Lot Number 21DKA509 ;
DYNJ903942D, Lot Number 21EKA062 ;
DYNJ904158B, Lot Number 19ABN292 ;
DYNJ904158B, Lot Number 19BBO282 ;
DYNJ904158B, Lot Number 19CBI653 ;
DYNJ906905B, Lot Number 22HMF046 ;
DYNJ906905B, Lot Number 22JMG038 ;
DYNJS3035, Lot Number 21GBL947 ;
DYNJS3035, Lot Number 21JBL374 ;
DYNJS3035, Lot Number 21KBF313 ;
DYNJS3035, Lot Number 21KBP406 ;
DYNJS3035, Lot Number 21KBW671 ;
DYNJS3035, Lot Number 21LBK410 ;
DYNJS3035, Lot Number 19ABP640 ;
DYNJS3035, Lot Number 22CBV726 ;
DYNJS3035, Lot Number 19CBT667 ;
DYNJS3035, Lot Number 22DBJ128 ;
DYNJS3035, Lot Number 22FBU254 ;
DYNJS3035, Lot Number 19EBZ680 ;
DYNJS3035, Lot Number 19FBH129 ;
DYNJS3035, Lot Number 22HBM446 ;
DYNJS3035, Lot Number 22IBB171 ;
DYNJS3035, Lot Number 22IBK248 ;
DYNJS3035, Lot Number 19HBN094 ;
DYNJS3035, Lot Number 19IBS848 ;
DYNJS3035, Lot Number 22KBN711 ;
DYNJS3035, Lot Number 22KBQ879 ;
DYNJS3035, Lot Number 19VBF591 ;
DYNJS3035, Lot Number 19LBX193 ;
DYNJS3035, Lot Number 20BBD198 ;
DYNJS3035, Lot Number 20BBJ243 ;
DYNJS3035, Lot Number 20BBR079 ;
DYNJS3035, Lot Number 23GBC631 ;
DYNJS3035, Lot Number 23GBU967 ;
DYNJS3035, Lot Number 23HBW879 ;
DYNJS3035, Lot Number 20HBM215 ;
DYNJS3035, Lot Number 20IBL253 ;
DYNJS3035, Lot Number 20IBM444 ;
DYNJS3035, Lot Number 20LBE454 ;
DYNJS3035, Lot Number 21ABW073 ;
DYNJS3035, Lot Number 21DBG410 ;
DYNJS3035, Lot Number 21DBT234 ;
DYNJS3035, Lot Number 21FBE207 ;
DYNJT1911D , Lot Number 21GBM854 ;
DYNJT1911D , Lot Number 21HBL482 ;
DYNJT1911D , Lot Number 21JBV094 ;
DYNJT1911D , Lot Number 21LBD977 ;
DYNJT1911D , Lot Number 19ABM480 ;
DYNJT1911D , Lot Number 22CBP276 ;
DYNJT1911D , Lot Number 19CBT157 ;
DYNJT1911D , Lot Number 22DBQ570 ;
DYNJT1911D , Lot Number 22FBP864 ;
DYNJT1911D , Lot Number 19FBH479 ;
DYNJT1911D , Lot Number 22HBV267 ;
DYNJT1911D , Lot Number 22JBG862 ;
DYNJT1911D , Lot Number 19TBA995 ;
DYNJT1911D , Lot Number 22LBD905 ;
DYNJT1911D , Lot Number 19KBI818 ;
DYNJT1911D , Lot Number 20BBX648 ;
DYNJT1911D , Lot Number 20DBF498 ;
DYNJT1911D , Lot Number 20EBJ723 ;
DYNJT1911D , Lot Number 20GBC611 ;
DYNJT1911D , Lot Number 20HBO933 ;
DYNJT1911D , Lot Number 20KBV620 ;
DYNJT1911D , Lot Number 20LBX239 ;
DYNJT1911D , Lot Number 21BBO242 ;
DYNJT1911D , Lot Number 21DBP011 ;
SPEC0150 , Lot Number 21JBS825 ;
SPEC0196B, Lot Number 21HBP822 ;
SPEC0196B, Lot Number 21HBP823 ;
SPEC0196B, Lot Number 21LBS523 ;
SPEC0196B, Lot Number 22BBG423 ;
SPEC0196B, Lot Number 19ABY909 ;
SPEC0196B, Lot Number 22DBD292 ;
SPEC0196B, Lot Number 22FBC357 ;
SPEC0196B, Lot Number 22IBC784 ;
SPEC0196B, Lot Number 22IBQ364 ;
SPEC0196B, Lot Number 22JBR506 ;
SPEC0196B, Lot Number 23ABA700 ;
SPEC0196B, Lot Number 23BBD104 ;
SPEC0196B, Lot Number 23EBI451 ;
SPEC0196B, Lot Number 23EBX572 ;
SPEC0196B, Lot Number 23FBB555 ;
SPEC0196B, Lot Number 20CBB650 ;
SPEC0196B, Lot Number 23GBJ028 ;
SPEC0196B, Lot Number 20CBY142 ;
SPEC0196B, Lot Number 23HBM323 ;
SPEC0196B, Lot Number 20GBH090 ;
SPEC0196B, Lot Number 20KBT647 ;
SPEC0196B, Lot Number 20KBT648 ;
SPEC0196B, Lot Number 21ABX189 ;
SPEC0196B, Lot Number 21CBN263 ;
SPEC0196B, Lot Number 21CBN441 ;
SPEC0279 , Lot Number 23LBF037 |
Recalling Firm/
Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
|
| For Additional Information Contact | Karin Johnson
886-359-1704 |
|---|
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. |
|---|
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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