| | Class 2 Device Recall Medline |  |
| Date Initiated by Firm | April 08, 2024 |
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| Date Posted | August 28, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2751-2024 |
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| Recall Event ID |
94581 |
| Product Classification |
General surgery tray - Product Code LRO
|
| Product | Medline procedural kits labeled as:
1) DRAWER 3 LAB DRAW & IV START, Pack Number ACC010417 ;
2) DRAWER 3 LAB DRAW & IV START, Pack Number ACC010417A;
3) DRAWER 9L , Pack Number ACC010427A;
4) MEDICATION DELIVERY MODULE, Pack Number ACC010605 ;
5) DRAWER 3, Pack Number ACC010641 ;
6) NEONATAL DRAWER 6 , Pack Number ACC010653 ;
7) DRAWER 2, Pack Number ACC010690 ;
8) ****, Pack Number ACC010690 ;
9) DRAWER 3, Pack Number ACC010784 ;
10) NURSERY CIRCUMCISION TRAY, Pack Number CIT4845;
11) CIRCUMCISION KIT, Pack Number CIT6535;
12) CIRCUMCISION TRAY, Pack Number CIT6720;
13) CIRCUMCISION TRAY, Pack Number CIT6720A;
14) MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780;
15) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920;
16) CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6925;
17) OSF SMMC CIRCUMCISION KIT, Pack Number CIT7095;
18) RETINA LAC/USC PACK , Pack Number CMPJ03205D;
19) AAA PACK-LF, Pack Number CMPJ09869B;
20) ****, Pack Number CMPJ21114P;
21) BRONCHOSCOPY KIT, Pack Number DYKE1764;
22) TRUNK KIT W/OUT EXPIRATION, Pack Number DYKM1360A ;
23) PRE OP KIT, Pack Number DYKS1256B ;
24) CIRCUMCISION TRAY, Pack Number DYNDA2271;
25) DMEK KIT, Pack Number DYNDA3103 ;
26) KIT, NICU - PICU , Pack Number DYNDL1576 ;
27) BASIC EYE PACK-LF , Pack Number DYNJ0413783N ;
28) VASCULAR PACK, Pack Number DYNJ34240I;
29) VASCULAR PACK-LF, Pack Number DYNJ52214 ;
30) SONDHEIMER, Pack Number DYNJ53853C;
31) BUCKLE PACK, Pack Number DYNJ57439A;
32) RETINA CUSTOM PACK, Pack Number DYNJ57970A;
33) AESC PHACO PACK, Pack Number DYNJ58135C;
34) PED RIGHT LEFT HEART PK MHS , Pack Number DYNJ58874 ;
35) PEDIATRIC RIGHT HEART PK MHS, Pack Number DYNJ58875 ;
36) CV MAJOR, Pack Number DYNJ64530 ;
37) ORL BRONCHOSCOPY PACK, Pack Number DYNJ80103A;
38) ISLET CELL , Pack Number DYNJ80490 ;
39) FREE FLAP TRAM ADD ON PACK, Pack Number DYNJ82179 ;
40) FREE FLAP TRAM ADD ON PACK, Pack Number DYNJ82179H;
41) ACCESSORY KIT, Pack Number DYNJ901348D;
42) AAA, Pack Number DYNJ905651B;
43) PROCEDURE TRAY , Pack Number DYNJRA0345F;
44) PROCEDURE TRAY , Pack Number DYNJRA1250B;
45) PROCEDURE TRAY , Pack Number DYNJRA1777;
46) BLOCK TRAY, Pack Number DYNJRA2352;
47) ADULT CORONARY PACK , Pack Number DYNJV0275O;
48) ****, Pack Number DYNJV0275O;
49) NURSING KIT, Pack Number EDUC05026 ;
50) RNSG 2308 , Pack Number EDUC1031;
51) RNSG 2308 , Pack Number EDUC1031H ;
52) RNSG 2201 , Pack Number EDUC1034;
53) RNSG 2201 , Pack Number EDUC1034H ;
54) RETINAL INJECTION KIT, Pack Number MNS12465;
55) ARTHROGRAPH TRAY, Pack Number MNS12670A;
56) PERIPHERAL ULTRASOUND CATHETER INSERTION, Pack Number MNS9865;
57) PERIPHERAL ULTRASOUND CATHETER, Pack Number MNS9865 ;
58) UVT KIT , Pack Number PAIN1396;
59) SHUNT PACK-LF, Pack Number PHS967363W;
60) GLMI ARTHROGRAM KIT:PCL, Pack Number SPEC0300B;
61) GLMI ARTHROGRAM KIT , Pack Number SPEC0300B ;
62) UA/UV CATHETERIZATION TRAY, Pack Number UVT1190B;
63) UMBILICAL TRAY , Pack Number UVT1195 ;
64) UVT KIT , Pack Number UVT1200 ;
65) UVT KIT , Pack Number UVT1200H;
66) UMBILICAL CATH KIT, Pack Number UVT1210 ;
67) UMBILICAL VESSEL TRAY W/O CATH, Pack Number UVT150;
68) UMBILICAL VESSEL CATHETER TRAY, Pack Number UVT665A ;
69) UMBILICAL VESSEL TRAY W/O CATH, Pack Number UVT915 |
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| Code Information |
ACC010417, Lot Numbers: 21JDC136;
ACC010417, Lot Numbers: 21LDA261;
ACC010417, Lot Numbers: 22BDA205;
ACC010417, Lot Numbers: 22FDB645;
ACC010417A , Lot Numbers: 23GDA903;
ACC010417A , Lot Numbers: 23HDA001;
ACC010417A , Lot Numbers: 23HDB495;
ACC010417A , Lot Numbers: 23IDA233;
ACC010417A , Lot Numbers: 23IDB522;
ACC010417A , Lot Numbers: 23JDB187;
ACC010427A , Lot Numbers: 23EDA979;
ACC010427A , Lot Numbers: 23IDB947;
ACC010605, Lot Numbers: 22LDB120;
ACC010605, Lot Numbers: 23ADB200;
ACC010605, Lot Numbers: 23ADB656;
ACC010605, Lot Numbers: 23BDA934;
ACC010641, Lot Numbers: 23GDC055;
ACC010653, Lot Numbers: 23HDC266;
ACC010690, Lot Numbers: 23IDA111;
ACC010690, Lot Numbers: 23IDB053;
ACC010690, Lot Numbers: 24CDB296;
ACC010784, Lot Numbers: 24CDA251;
CIT4845, Lot Numbers: 2022070190;
CIT6535, Lot Numbers: 2023122680;
CIT6720, Lot Numbers: 2022050290;
CIT6720, Lot Numbers: 2023052690;
CIT6720A, Lot Numbers: 2023111090;
CIT6780, Lot Numbers: 2023052690;
CIT6920, Lot Numbers: 2022030890;
CIT6925, Lot Numbers: 2022051690;
CIT6925, Lot Numbers: 2022101090;
CIT6925, Lot Numbers: 2023062690;
CIT7095, Lot Numbers: 2022071390;
CMPJ03205D , Lot Numbers: 24BBI377;
CMPJ09869B , Lot Numbers: 23HMH649;
CMPJ09869B , Lot Numbers: 23KMB759;
CMPJ09869B , Lot Numbers: 24AME944;
CMPJ21114P , Lot Numbers: 24CBJ402;
DYKE1764 , Lot Numbers: 22FBS049;
DYKE1764 , Lot Numbers: 23ABO112;
DYKE1764 , Lot Numbers: 23CBR915;
DYKE1764 , Lot Numbers: 23IBF012;
DYKM1360A, Lot Numbers: 23FBT211;
DYKS1256B, Lot Numbers: 21CBR391;
DYKS1256B, Lot Numbers: 21DBV160;
DYKS1256B, Lot Numbers: 21HMG454;
DYKS1256B, Lot Numbers: 22AMG240;
DYKS1256B, Lot Numbers: 22DMF530;
DYKS1256B, Lot Numbers: 23CMD114;
DYKS1256B, Lot Numbers: 23GMA886;
DYKS1256B, Lot Numbers: 23HMH613;
DYNDA2271, Lot Numbers: 2022070190;
DYNDA3103, Lot Numbers: 24BBA889;
DYNDL1576, Lot Numbers: 23DBF325;
DYNDL1576, Lot Numbers: 23FBF144;
DYNDL1576, Lot Numbers: 24ABO204;
DYNDL1576, Lot Numbers: 24BBO954;
DYNJ0413783N, Lot Numbers: 23IMC236;
DYNJ0413783N, Lot Numbers: 23JMB485;
DYNJ34240I , Lot Numbers: 21KBQ916;
DYNJ34240I , Lot Numbers: 21KBQ921;
DYNJ34240I , Lot Numbers: 22FBJ330;
DYNJ34240I , Lot Numbers: 22JBN374;
DYNJ34240I , Lot Numbers: 23JMI380;
DYNJ34240I , Lot Numbers: 23KME465;
DYNJ34240I , Lot Numbers: 23LMB750;
DYNJ52214, Lot Numbers: 22GBM584;
DYNJ52214, Lot Numbers: 23EBV426;
DYNJ52214, Lot Numbers: 23FBQ525;
DYNJ52214, Lot Numbers: 23LBO633;
DYNJ52214, Lot Numbers: 24BBJ934;
DYNJ52214, Lot Numbers: 24BBT876;
DYNJ52214, Lot Numbers: 20LBO359;
DYNJ53853C , Lot Numbers: 21FMA744;
DYNJ53853C , Lot Numbers: 21FMB832;
DYNJ53853C , Lot Numbers: 22BMG093;
DYNJ53853C , Lot Numbers: 22IMG468;
DYNJ57439A , Lot Numbers: 21KBR361;
DYNJ57439A , Lot Numbers: 22JBF797;
DYNJ57439A , Lot Numbers: 22KBK481;
DYNJ57970A , Lot Numbers: 21FBT988;
DYNJ58135C , Lot Numbers: 23EBB779;
DYNJ58135C , Lot Numbers: 23FBD603;
DYNJ58135C , Lot Numbers: 23FBT783;
DYNJ58135C , Lot Numbers: 23JBT096;
DYNJ58135C , Lot Numbers: 21BMA342;
DYNJ58135C , Lot Numbers: 21CMC960;
DYNJ58135C , Lot Numbers: 21EMA605;
DYNJ58135C , Lot Numbers: 21FMA438;
DYNJ58135C , Lot Numbers: 21GMD933;
DYNJ58135C , Lot Numbers: 22AMF725;
DYNJ58874, Lot Numbers: 22EBP939;
DYNJ58874, Lot Numbers: 23FBR955;
DYNJ58874, Lot Numbers: 23FBT080;
DYNJ58875, Lot Numbers: 23FBM015;
DYNJ58875, Lot Numbers: 23GBD061;
DYNJ58875, Lot Numbers: 23JBW886;
DYNJ64530, Lot Numbers: 23IBS196;
DYNJ80103A , Lot Numbers: 23HBN888;
DYNJ80103A , Lot Numbers: 23IBE224;
DYNJ80490, Lot Numbers: 22FDB938;
DYNJ82179, Lot Numbers: 23IDB760;
DYNJ82179H , Lot Numbers: 23IDB760;
DYNJ901348D , Lot Numbers: 22CBN435;
DYNJ901348D , Lot Numbers: 22GBN021;
DYNJ901348D , Lot Numbers: 22IBL110;
DYNJ901348D , Lot Numbers: 22JBO112;
DYNJ901348D , Lot Numbers: 23CBJ265;
DYNJ901348D , Lot Numbers: 23DBG454;
DYNJ901348D , Lot Numbers: 23HBJ345;
DYNJ901348D , Lot Numbers: 23IBV193;
DYNJ901348D , Lot Numbers: 23JBU781;
DYNJ905651B , Lot Numbers: 23IMH419;
DYNJ905651B , Lot Numbers: 23LMG546;
DYNJ905651B , Lot Numbers: 24BME750;
DYNJRA0345F , Lot Numbers: 23ABR895;
DYNJRA1250B , Lot Numbers: 22EBF982;
DYNJRA1250B , Lot Numbers: 23FMC743;
DYNJRA1250B , Lot Numbers: 23FMF948;
DYNJRA1250B , Lot Numbers: 23JMG164;
DYNJRA1777 , Lot Numbers: 23CBE622;
DYNJRA2352 , Lot Numbers: 24BBJ316;
DYNJV0275O , Lot Numbers: 24AMH648;
DYNJV0275O , Lot Numbers: 24CME159;
EDUC05026, Lot Numbers: 21HDB123;
EDUC05026, Lot Numbers: 21HDC026;
EDUC05026, Lot Numbers: 21IDB633;
EDUC05026, Lot Numbers: 21JDB157;
EDUC05026, Lot Numbers: 21KDB162;
EDUC05026, Lot Numbers: 21LDA686;
EDUC05026, Lot Numbers: 22ADA717;
EDUC05026, Lot Numbers: 22BDB179;
EDUC05026, Lot Numbers: 22DDA921;
EDUC1031 , Lot Numbers: 23BLA800;
EDUC1031H, Lot Numbers: 23BLA800;
EDUC1034 , Lot Numbers: 23CLA376;
EDUC1034H, Lot Numbers: 23CLA376;
MNS12465, Lot Numbers: 2022081990;
MNS12670A, Lot Numbers: 2022050290;
MNS9865, Lot Numbers: 2022051050;
MNS9865 , Lot Numbers: 23EMI898;
PAIN1396 , Lot Numbers: 22FBN139;
PHS967363W , Lot Numbers: 23JMB678;
SPEC0300B, Lot Numbers: 2021090750;
SPEC0300B, Lot Numbers: 2022051050;
SPEC0300B, Lot Numbers: 23JBD693;
SPEC0300B, Lot Numbers: 23KBH304;
SPEC0300B, Lot Numbers: 24ABS449;
UVT1190B , Lot Numbers: 24ABS540;
UVT1195 , Lot Numbers: 22FBN138;
UVT1200 , Lot Numbers: 22FBN139;
UVT1200H , Lot Numbers: 22FBN139;
UVT1210 , Lot Numbers: 22GBH327;
UVT1210 , Lot Numbers: 22JBT476;
UVT1210 , Lot Numbers: 22JBU369;
UVT1210 , Lot Numbers: 23FBB299;
UVT1210 , Lot Numbers: 23GBA743;
UVT1210 , Lot Numbers: 23JBK029;
UVT1210 , Lot Numbers: 23LBM731;
UVT150, Lot Numbers: 22FBX796;
UVT150, Lot Numbers: 22HBN579;
UVT150, Lot Numbers: 22JBI343;
UVT150, Lot Numbers: 22JBN119;
UVT150, Lot Numbers: 23BBJ954;
UVT150, Lot Numbers: 23EBS525;
UVT150, Lot Numbers: 23GBD813;
UVT150, Lot Numbers: 23GBR233;
UVT150, Lot Numbers: 23IBS687;
UVT150, Lot Numbers: 23JBY235;
UVT665A , Lot Numbers: 22FBK838;
UVT665A , Lot Numbers: 22IBV837;
UVT665A , Lot Numbers: 22KBQ011;
UVT665A , Lot Numbers: 23GBD803;
UVT665A , Lot Numbers: 23IBI160;
UVT915, Lot Numbers: 23CBN895;
UVT915, Lot Numbers: 23JBY224 ;
|
Recalling Firm/
Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
|
| 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 the 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 |
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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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